Zimmer Hip Implants Receive FDA Warning Over Practices in Manufacturing Plant
By Andrea Gressman
The FDA issued a warning to Zimmer Holdings Inc. regarding its operations for manufacturing and testing of one of its metal on metal hip implants at one of its locations. In a letter written on September 19, 2012, the agency stated that Zimmer failed to comply with federal regulations regarding its production of the Zimmer hip implant, the Trilogy Acetabular System, which was being produced at its Ponce, Puerto Rico plant.
According to CNBC, the FDA warning highlighted two distinct failures in meeting federal standards: one was in testing the metal hip implant to uphold design specs, and the other was providing concrete evidence regarding the safety of manufacturing products with metallic spikes.
Zimmer’s regulatory filing indicated the FDA did not halt production or ban shipment of the Zimmer hip implant in light of the warning, which came after an inspection in June. The company did, however, volunteer to temporarily suspend the release of the Zimmer Trilogy Acetabular System hip implant.
Zimmer reported the completion of its validation of spike-free devices within the Trilogy hip implant line and will do the same for spiked products in the near future.
Zimmer Hip Implant Side Effects
The FDA warning simply adds to the pile in a number of issues regarding Zimmer’s metal on metal hip implant devices. The company is dealing with several Zimmer hip implant lawsuits regarding its Durom Cup, which is a metal socket designed for use in total hip replacement procedures.
Though the Zimmer Durom hip implant device was approved by the FDA in 2006, only a short time passed before it got the attention of orthopedic surgeons and patients, who noticed a loosening of the Zimmer hip implant cup and failure of the device quickly after implantation. The result of this failure was excruciating pain. Artificial hips are said to last around 15 years or so, but this was clearly not the case with many of Zimmer’s metal on metal hip implant products.
During an investigation of the Durom Cup, Zimmer issued a recall of the device for about two months. The investigation involved over 3,000 patients, which concluded a lack of training by doctors on proper implantation of the metal hip replacement system. The FDA reported the Durom Cup’s recall was a direct result of inadequate instructions for surgical implantation and use. The Zimmer Durom Cup hip implant was eventually put back on the market.
Metal on Metal Hip Implant Side Effects
Metal on metal hip implant devices have been the subject of many lawsuits and class action lawsuits against many manufacturers due to early failure rates, which require extensive corrective surgeries. Another serious side effect of metal on metal hip implants is metallosis. Metallosis occurs when metal shards break off and enter the blood stream resulting in metal poisoning. The metal parts rub against each other, causing sections to break off.
Other metal hip implant side effects include:
Pain
Swelling
Dislocated Hip
Cancer
Loss of bone strength/bone fractures
Tissue death
Non-cancerous tumors/pseudotumors
Cobalt poisoning
If you experienced any of these metal on metal hip implant side effects, you may have a legal claim to seek compensation through a metal hip implant injury lawsuit settlement.
Zimmer Hip Implant Lawsuits and MDL
Federal lawsuits against Zimmer regarding its Durom Cup still continue in a consolidated multidistrict litigation in the District of New Jersey. Judge Susan D. Wigenton is presiding over the Zimmer hip implant lawsuit MDL.
If you or someone you love has experienced negative side effects due to the Zimmer hip implant product, consult a Zimmer lawsuit specialist right away. Visit the DePuy, Biomet, Wright Medical Technology & Zimmer, Metal on Metal Hip Implant Class Action Lawsuit Investigation page. Zimmer lawsuit attorneys are currently investigating a variety of Zimmer hip implant side effects including early failure, those who have had to receive corrective surgeries, metallosis, an increased risk of cancer, non-cancerous tumors surrounding the hip implant site which can cause pain, degenerative heart disease cardiomyopathy, and swelling inflammation and severe discomfort.
Updated October 8th, 2012
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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