Medical device manufacturer Zimmer is recalling one of its femoral stem and neck components used in hip replacement surgeries because higher than expected levels of manufacturing residues were left on the devices. These residues may cause patients to experience allergic reactions, pain, infections or death, and revision surgery may be needed to replace the defective devices.
The recall involves the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks, which are Tivanium alloy implants that allow the surgeon to fit the implant specifically to the patient. During hip replacement surgery, the damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck.
Zimmer has contacted medical facilities with the affected implants and instructed them to quarantine the devices. Surgeons have also been informed of the recall. Health care professionals and patients are encouraged to report any adverse events associated with these devices to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting System at www.FDA.gov/MedWatch/Report.htm.
Zimmer has been plagued with problems involving its various implants. The company’s hip replacement systems with metal-on-metal technology are already under review by federal regulators, as are similarly designed hip implants by other manufacturers because the devices can corrode inside the body, inflaming and damaging tissue and causing a type of blood poisoning known as metallosis. In 2012, Zimmer pulled from the market its Durom Acetabular Cup, a component used in hip replacement surgeries, also because of early failures.
In March, Zimmer issued a worldwide voluntary recall of its Persona Trabecular Metal Tibial Plate, a component used in the Zimmer Persona Knee implant, after receiving multiple reports of premature failure. The company is also facing lawsuits involving its NexGen knee implant, which was also found to fail prematurely.