An Exactech total knee replacement system has been linked to multiple complications and numerous patients have had to undergo revision surgery. The FDA has received multiple injury reports indicating that the Optetrak total knee replacement made by Exactech was prematurely failing, reportedly due to tibial insert wear and tear of the implant.
The Exactech total knee replacement is typically prescribed to patients who suffer knee damage or deterioration and wish to regain joint function.
Knee replacement surgery is conducted on a daily basis in the United States, with approximately 4.4 million Americans having undergone the procedure. The Exactech total knee replacement system has been available for several years, with the company experiencing many years of success. However, early failure rates allegedly began as early as 2008, with patients alleging they needed revision surgery due to knee implant complications.
Recently, there have been several recalls of certain total knee replacements due to implant complications and device failures. The Exactech total knee replacement has been linked to high failure rates and patients reporting the need for revision surgery.
Overview of Exatech Total Knee Replacement Problems
According to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, numerous patients have reported early device failure in the Exactech total knee replacement. MAUDE looked into numerous injury reports trying to identify the cause of the knee replacement complications and found that certain components of the device may be prone to early wear and fretting.
Additionally, a recent study analyzed the rate of device failure in conjunction with the Exactech total knee replacement. The inquiry was done by Orthopaedics & Traumatology: Surgery & Research, which analyzed 110 prostheses in 106 patients within 25 months after undergoing knee replacement surgery. The study found the following statistic after the results were consolidated:
- 15% of patients reported they were disappointed or dissatisfied with the knee implant
- 22% of patients reported they needed painkillers on a regular basis
- 22% of patients reported experiencing early signs of tibial implant loosening
- 21% of patients reported experiencing patellofemoral problems
- 13 patients reported needing revision surgery due to: tibial loosening, patellofemoral instability, or patellofemoral pain
Researchers stated that the components at issue are the cement-tibial-implant interface. When the knee implant starts to wear or fret, plastic fragments are shed into the bloodstream and can cause multiple problems including:
- Debilitating Pain
- Limited Mobility
- Swelling
- Infections
- Fractures
- Disassociation of Implant
- Inflammation
- Device Loosening
- Patellofemoral Tracking-Lateral Release (dislocation of kneecap)
The above-listed problems have forced numerous patients to undergo revision surgery, which is considered riskier than the initial implant surgery due to a higher risk of infection. Patients who contend with revision surgery not only face longer recovery periods but also expensive medical bills.
Some patients may be in a position to file legal action against the manufacturing company, alleging claims for negligence and failure to warn. With early failure reports stemming as far back as 2008, it could be that Exactech knew about these device problems and should have provided a proper warning.
Get a Free Knee Replacement Case Review
If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.
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