Tennessee Medical Device Failure Lawyer

A hip or knee replacement is supposed to restore mobility and reduce pain. When an implanted medical device fails prematurely, however, the consequences can be devastating.

Patients may face renewed pain, loss of mobility, tissue and bone damage, metal debris, elevated cobalt or chromium levels, implant fracture, loosening, instability, and the prospect of another major operation to remove or revise the failed device.

At GILREATH LAW, PLLC, attorney R. Christopher Gilreath represents people seriously injured by defective and prematurely failing medical devices in Tennessee. Based in Memphis and handling serious injury litigation throughout Tennessee, including Nashville and Middle Tennessee, our practice focuses on cases where significant injuries require detailed investigation, sophisticated medical evidence, and litigation against well-funded defendants.

Medical-device cases are not simply medical-malpractice cases. Determining why an implant failed can require analysis of the device itself, its design and materials, FDA records, manufacturer documents, adverse-event reports, recalls, medical imaging, laboratory testing, operative records, pathology, and sometimes the physical components removed during revision surgery.

When an implanted device fails, the question is not simply what happened to the patient.

The critical question may be:

Why did this particular implant fail?

Hip Replacement and Hip Implant Failure Cases

Total hip replacement is one of the most commonly performed and successful orthopedic procedures. But the enormous number of hip replacements performed also means that even a relatively small percentage of premature failures can affect thousands of patients.

The American Joint Replacement Registry maintained through the American Academy of Orthopaedic Surgeons has become the largest U.S. registry of hip and knee arthroplasty procedures by annual procedural count. By 2024, the registry had surpassed 4 million captured hip and knee procedures, with its 2024 annual report analyzing more than 3.7 million procedures performed between 2012 and 2023. The registry has since grown to more than 5 million recorded procedures.

These operations generally produce good outcomes. But implant survivorship statistics also demonstrate why the circumstances of an unusually early failure deserve careful investigation.

A large registry study of total hip arthroplasties reported overall 10-year implant survival of 93.6%. Importantly, age mattered substantially: patients receiving a hip replacement between ages 46 and 50 had an estimated lifetime revision risk of 27.6%, compared with much lower lifetime risks among older patients. Common reasons for revision included aseptic loosening, infection, periprosthetic fracture, and dislocation.

Those population statistics do not establish whether any particular implant was defective. They provide context. A patient's actual case requires investigation of the specific implant, failure mechanism, medical history, implantation technique, manufacturer information, and available scientific and regulatory evidence.

Why Do Hip Implants Fail?

Hip replacement systems contain multiple components subjected to substantial mechanical forces over millions of cycles of ordinary movement.

Potential failure mechanisms can include:

• premature loosening of the femoral or acetabular component;
• wear and generation of metallic or polyethylene debris;
• corrosion at modular component junctions;
• fretting and mechanically assisted crevice corrosion;
• cobalt and chromium release;
• adverse local tissue reactions;
• osteolysis and bone loss;
• implant fracture or component breakage;
• femoral stem fracture;
• failure at modular junctions;
• dislocation or instability;
• component migration;
• infection; and
• premature failure requiring revision surgery.

The FDA identifies loosening or breakage, bone loss, fracture, dislocation, infection, nerve injury, and local or systemic reactions to particles or ions generated by an implant among the potential adverse events associated with hip replacement systems.

Some of these complications can occur without a defective product. Others may raise significant questions about the design, manufacture, materials, warnings, or performance of the implant.

That distinction is one of the central issues in a medical-device case.

Cobalt-Chromium Hip Implants, Corrosion, and Metal Debris

One of the most significant issues in modern hip-implant litigation involves cobalt-chromium components and the release of metallic debris and metal ions.

Cobalt-chromium alloys have been widely used in orthopedic implants because of their strength, wear resistance, and corrosion resistance. But “corrosion resistant” does not mean incapable of corrosion.

Metal can be released not only where two bearing surfaces articulate but also at junctions where separate implant components connect.

The FDA specifically recognizes that wear and corrosion at the connection between the metal femoral head and the taper of the stem can occur and that cobalt and chromium ions generated from implant materials may enter the bloodstream.

This can become particularly important in modular hip systems.

Trunnionosis and Taper Corrosion

The femoral head of many total hip replacements attaches to the stem at a tapered connection commonly referred to as the head-neck taper or trunnion.

Micromotion, mechanical stresses, electrochemical processes, material combinations, component geometry, and other factors can contribute to fretting and corrosion at this junction.

This phenomenon is sometimes referred to as:

trunnionosis, taper corrosion, fretting corrosion, or mechanically assisted crevice corrosion.

When corrosion occurs, metallic debris and ions may be released into surrounding tissues and potentially into the bloodstream.

Importantly, corrosion issues are not necessarily limited to traditional metal-on-metal bearing surfaces. Published research examining failed metal-on-polyethylene total hip replacements has also documented corrosion and release of metal ions from some components.

That distinction matters because a patient can potentially experience a metal-related implant problem even when the hip is not what patients commonly understand to be a traditional “metal-on-metal hip.”

Cobalt and Chromium: What Happens When Metal Is Released?

Metal debris around a failing hip implant may provoke an inflammatory response.

The FDA describes tissue reactions associated with metallic wear debris as adverse local tissue reactions (ALTR) and describes local and systemic responses collectively as adverse reactions to metal debris (ARMD). Progressive tissue damage may involve bone, muscle, nerves, and other soft tissues surrounding the joint.

Potential findings associated with a failing metal-containing hip implant can include:

• elevated blood cobalt levels;
• elevated chromium levels;
• metallosis;
• synovitis;
• fluid collections;
• pseudotumor formation;
• necrosis or destruction of surrounding tissue;
• muscle damage;
• osteolysis;
• loosening;
• pain;
• weakness;
• instability; and
• eventual revision surgery.

The FDA's postmarket surveillance work involving metal-on-metal total hip replacements found that whole-blood and serum cobalt and chromium levels were significantly higher in metal-on-metal hip patients than in control patients without metal implants. At the same time, FDA cautions that a single metal-ion number cannot by itself establish implant failure or the need for revision.

That is an important distinction.

A medical-device case should not be evaluated from a cobalt number alone. Laboratory results need to be considered together with symptoms, implant identification, serial testing, imaging, operative findings, pathology, component position, and evidence concerning the particular device.

Metal-on-Metal Hip Implant Failures

Metal-on-metal hips deserve particular attention because of their regulatory and clinical history.

In these systems, metallic surfaces can generate particles through wear. Metal can also be released through corrosion at modular connections.

The FDA reports that accumulated metal debris in some patients can damage bone and tissue surrounding the implant. This damage may lead to pain, loosening, device failure, and revision surgery.

The regulatory history is also significant.

In 2016, FDA required manufacturers seeking to continue marketing certain metal-on-metal total hip replacement systems to obtain premarket approval, the agency's more stringent Class III approval pathway. According to FDA, there are currently no FDA-approved metal-on-metal total hip replacement devices legally marketed in the United States, although patients who underwent hip replacement before May 18, 2016 may still have these implants. Metal-on-metal hip resurfacing devices are a separate category.

For patients with older implants who develop unexplained hip pain, weakness, swelling, gait changes, abnormal imaging, elevated metal-ion levels, or the need for revision, identifying the exact implanted components can therefore be extremely important.

Hip Implant Fractures and Component Breakage

An orthopedic implant must withstand substantial repetitive loading over years of use.

When a femoral stem, modular neck, taper, screw, liner, acetabular component, or another structural component fractures, the failure deserves careful investigation.

An implant fracture does not automatically prove that the product was defective. Relevant issues can include patient anatomy, trauma, activity, component positioning, fixation, bone support, and other clinical factors.

But the investigation should also examine the device itself.

Potential issues can include:

• fatigue failure;
• material defects;
• metallurgical abnormalities;
• manufacturing defects;
• inadequate component dimensions;
• stress concentrations;
• corrosion-assisted fatigue;
• fretting;
• failure of a modular connection;
• surface or machining defects; and
• whether similar fractures have occurred in the same product line.

The fracture surface itself may contain valuable evidence concerning how the device failed.

For that reason, preserving an explanted fractured device can become critically important.

Knee Replacement Implant Failures

Hip implants are not the only orthopedic devices capable of premature failure.

Total knee replacement components can fail through loosening, wear, fracture, instability, fixation problems, component migration, or other mechanisms.

Large registry studies demonstrate that most knee replacements have substantial longevity. One registry analysis reported 95.6% overall survival at 10 years. But age again mattered substantially. Patients between ages 46 and 50 had an estimated 22.4% lifetime risk of revision, with aseptic loosening, infection, and unexplained pain among the most common reasons for revision.

A separate Scottish registry analysis likewise found that estimated lifetime revision risk varied dramatically with age, reaching 32.7% among patients ages 45–49 in that population.

These studies should not be interpreted to mean that those percentages represent defective-device rates. Revision can occur for many reasons unrelated to a product defect.

But when a knee replacement fails unusually early—or when the same model demonstrates a recurring failure mechanism—the device itself should be investigated.

Potential knee implant failure issues can include:

• tibial baseplate loosening;
• tibial component fracture;
• polyethylene insert wear or failure;
• femoral component loosening;
• instability;
• component migration;
• loss of fixation;
• cement-interface problems;
• metallosis or wear debris;
• mechanical breakage; and
• premature revision.

Revision Surgery Is Not the Same as the Original Joint Replacement

A patient who undergoes revision surgery has already endured the original joint replacement.

Now the patient may face another major operation because the implanted joint has failed.

Revision surgery can involve removal of well-fixed components, loss of additional bone, reconstruction of damaged tissue, larger or more complex replacement components, longer recovery, and the possibility of additional future procedures.

Revision also does not necessarily end the problem.

Research involving Medicare patients has demonstrated substantially lower five-year implant survival after revision hip and knee procedures than after primary joint replacement, illustrating the additional long-term burden associated with revision arthroplasty.

For someone who expected an implant to restore mobility for many years, premature failure can therefore represent much more than another operation.

It can alter the patient's orthopedic future.

FDA Medical Device Records Can Be Critical Evidence

One of the first questions in a potential implant case should be:

Exactly what device was implanted?

Manufacturer, product family, model number, catalog number, lot number, component sizes, and sometimes the device's Unique Device Identifier can matter.

Once the implant is identified, the investigation may include FDA regulatory records concerning the device.

Relevant sources can include:

• FDA approval or clearance records;
• 510(k) records;
• Premarket Approval (PMA) materials;
• recalls;
• safety communications;
• manufacturer correction or removal actions;
• postmarket surveillance studies;
• Medical Device Reports;
• FDA enforcement information; and
• MAUDE adverse-event reports.

The FDA maintains a searchable Medical Device Recall database containing classified medical-device recalls dating back to November 2002. Search FDA Medical Device Recalls.

The agency also maintains the Manufacturer and User Facility Device Experience—or MAUDE—database containing reports of deaths, injuries, malfunctions, and other adverse events associated with medical devices. Search the FDA MAUDE database.

An Important Limitation of FDA Adverse-Event Numbers

Numbers from the MAUDE database must be interpreted carefully.

The FDA expressly warns that Medical Device Reports cannot, standing alone, be used to calculate the incidence or prevalence of a complication, compare failure rates between devices, or establish that a device caused a reported injury.

Reports can be incomplete, duplicated, inaccurate, unverified, or subject to underreporting.

At the same time, adverse-event reports can be highly valuable investigative information.

They may help identify reported failure modes, similar events involving the same device family, patterns requiring additional investigation, and information that should be compared against recalls, scientific literature, registry data, manufacturer records, and evidence developed through litigation.

As of 2026, FDA reports receiving more than two million medical-device reports annually involving suspected device-associated deaths, serious injuries, and malfunctions.

The important question is not simply how many reports exist.

It is what the evidence shows about the particular device and the particular failure.

How We Investigate a Failed Hip or Knee Implant Case

Medical-device litigation requires considerably more than obtaining medical records and proving that a patient underwent revision surgery.

A serious investigation may require reconstructing the entire history of the implant—from its regulatory pathway and design through implantation, failure, explantation, and laboratory examination.

Important evidence can include the original operative report, implant stickers and device-identification records, postoperative imaging, serial X-rays, CT or MRI studies, cobalt and chromium laboratory testing, aspiration results, pathology, revision operative reports, photographs, explanted components, FDA records, manufacturer literature, recall information, adverse-event reports, peer-reviewed medical literature, joint-registry evidence, and testimony from orthopedic, engineering, metallurgical, pathology, toxicology, or other experts.

The goal is to determine whether the patient's injury resulted from an expected complication—or whether evidence supports a failure associated with the device's design, manufacture, materials, warnings, or performance.

Preserve the Explanted Medical Device

One of the most important issues in a potential implant-failure case can arise before revision surgery occurs.

If a surgeon removes a failed implant, the physical device itself may become critical evidence.

The explanted components may contain evidence of:

• fracture initiation and propagation;
• corrosion;
• fretting;
• scratching or abnormal wear;
• material transfer;
• deformation;
• component impingement;
• surface damage;
• manufacturing abnormalities; and
• the mechanical relationship between components.

Once discarded or returned without appropriate preservation procedures, that evidence may be difficult or impossible to recreate.

For that reason, patients considering revision surgery after a suspected device failure should speak with an attorney experienced in serious medical-device litigation as early as possible.

Symptoms That May Warrant Investigation of a Hip Implant

The FDA advises patients with hip implants to pay attention to symptoms that can include pain in the hip, groin, or leg; swelling around the joint; changes in walking ability; and popping, grinding, clicking, or squeaking noises.

Depending upon the implant and circumstances, other potentially important findings may include weakness, recurrent instability, unexplained loss of mobility, abnormal imaging, elevated cobalt or chromium levels, fluid collections, tissue destruction, osteolysis, component migration, or a physician's recommendation for revision surgery.

These symptoms do not necessarily mean that an implant is defective.

They do mean the cause of the problem may deserve investigation.

Tennessee Medical Device and Implant Failure Cases

Defective medical-device litigation can be substantially more complicated than an ordinary Tennessee personal injury case.

Manufacturers may be headquartered outside Tennessee. Devices may have been designed, tested, manufactured, or cleared elsewhere. Regulatory evidence may span many years. Similar cases may be pending throughout the United States.

Claims can potentially involve allegations concerning defective design, defective manufacture, inadequate warnings or instructions, breach of applicable warranties, misrepresentation, negligence, and other theories available under applicable product-liability law.

Which claims actually apply depends on the particular product, its regulatory history, the evidence, and the governing law.

These cases can also raise sophisticated federal issues involving FDA regulation and federal preemption. The regulatory pathway followed by a particular device—including whether it entered the market through FDA's 510(k) process or Premarket Approval process—can materially affect the legal analysis.

That is why a medical-device case should be evaluated based on the specific implant, not simply the patient's diagnosis.

Serious Medical Device Litigation in Memphis, Nashville, and Across Tennessee

GILREATH LAW represents people with serious injuries throughout Tennessee.

From Memphis and West Tennessee to Nashville and Middle Tennessee, and in serious cases across the state, our focus is litigation involving injuries significant enough to require detailed investigation and trial preparation.

Medical-device manufacturers and their insurers have access to sophisticated lawyers, engineers, medical experts, scientists, and enormous financial resources.

A seriously injured patient should expect the same level of preparation on his or her side of the case.

Attorney R. Christopher Gilreath focuses his practice on serious personal injury litigation and prepares significant cases with the expectation that the evidence—not simply the existence of an injury—must ultimately prove the case.

Attorney experience

Medical device litigation is a focus of Christopher Gilreath's personal injury case practice. Pantuso v. Wright Medical Technology: Co-counsel representing a Utah victim of a defective titanium hip implant.  The case set a precedent in Tennessee for choice of venue for hip implant failures for victims nationally, leading to multi-victim coordinated litigation resulting in significant compensation for multiple victims.  He has since worked on cases involving cobalt-chromium corrosion, implant fractures, and disassociation events involving multiple manufacturers.

He has also taught other trial lawyers about these cases, including “Handling Medical Device Cases” for the Southern Trial Lawyers Association (2021) and “Medical Device Cases – Screen Them Differently” for the Tennessee Trial Lawyers Association (2019).

Handled before founding Gilreath Law, PLLC, together with other counsel. Past results do not guarantee a similar outcome. All advertised results are based on past cases and their individual facts and circumstances. The outcome of your case will depend on your unique facts and circumstances.

Serving clients across Tennessee

We represent defective medical devices clients from our principal office in Memphis, with private client meetings in Nashville by appointment only, and throughout Knoxville and East Tennessee.

Frequently Asked Questions About Hip, Knee, and Medical Device Failure Cases

When an Implant Fails, Find Out Why

A failed hip or knee replacement can change the course of a person's life.

Revision surgery may mean another hospitalization, another period of rehabilitation, additional pain, additional medical expense, loss of mobility, time away from work, and uncertainty about how well the reconstructed joint will function in the future.

But the fact that an implant failed does not answer the most important question.

Was the failure an unavoidable medical complication—or did something go wrong with the device?

Answering that question requires investigation.

GILREATH LAW represents seriously injured people in Memphis, Nashville, and throughout Tennessee in significant personal injury and product-liability litigation.

If you have undergone—or have been told that you may need—revision surgery because of a fractured, corroded, loosened, or otherwise failing hip, knee, or other implanted medical device, contact GILREATH LAW, PLLC to discuss whether the device and the circumstances surrounding its failure should be investigated.

R. Christopher Gilreath Trial Attorney GILREATH LAW, PLLC Memphis, Tennessee (901) 343-6337

Written and reviewed by attorney R. Christopher Gilreath. Last updated October 4, 2026. This page provides general information, not legal advice. No attorney fee is charged unless we recover compensation for you. Depending on your written fee agreement, you may be responsible for case costs and expenses.