Zimmer Durom Cup: Quotes from the FDA Recall Packet

Zimmer Holdings suspended sales of the Durom® Cup in July 2008, after the alleged failure of the implant required additional surgeries.

The same product had been very successfully used in hip replacement surgeries since 2001, in international markets.

So what happened?

Zimmer alleges that the problem was that the doctors installing the cup were not properly trained, and needed additional workshops.

I would like to call your attention to the FDA Durom Cup Recall Packet, dated September 26th, 2007, 162 pages, PDF readily available online, loaded with information.

The recall packet starts with another problem, and it is an interesting one:

Page One
The recall packet begins with a product recall dated September 26th, 2007 – it states,
“Zimmer GmbH is initiating a product recall of the DUROM Femoral Component 54 Code T and the Femoral Component 46 Code L…. This action is being conducted because some products of the above mentioned lot have been mixed up during packaging. The packaging for the 54 mm implant from this lot may contain a 46 mm implant and vice versa.”

Page Five
“Description of event: The packaging contains the incorrect device. In packages labeled for the 54mm, there is a 46 mm and vice versa.”

“…it was determined that inadequate work instruction and line clearance activities were the primary root causes. A risk analysis from this investigation was developed leading to a corrective and preventive action plan.”

Page Fourteen – Fifteen (from the Health Hazard Analysis Section)

“Discoverability: There is a very high degree of probability that a misidentified femoral component can be discovered by the end user when opened in surgery. The size difference for the two components is 8mm for both the outer diameter and the inner diameter of the sphere. The misidentified product would be removed from the package after the femoral bone cuts have already been made…

“… a 46mm implant coming out of the 54 mm packaging would be discovered as it has an inner dimension of 39.4mm and would not fit on a bony stump prepared for a 54mm implant.

…a 54mm implant coming out of the 46mm packaging would be discovered as it has an inner dimension of 47.4 and would be grossly loose if placed on bony stump prepared for a 46mm implant.”

Page Seventeen
“To upsize or downsize 2mm the femoral head. To downsize he would have to remove more femoral bone. To upsize he would have to apply a thicker cement mantle to fit the bone cut for a 46mm. In either case, the fit in the natural acetabulum would not be ideal.”

At the bottom of the page,
“Outcome 4: It is an extremely remote probability that an end user would not notice the 8mm difference in the implants. A large mismatch between the femoral head and the acetabular surface (natural or implant) would occur leading to instability, patient pain, compromised leg length, and certain revision surgery. Again, this is considered remote in probability.”

On page 21 the FDA says it agrees with Zimmer’s action to recall because of mislabeling, because otherwise they’d have to start legal action to remove it from the market. They go on to say:

“These recalls have been classified by the FDA as Class II recalls, since FDA considers these devices to be adulterated and/or misbranded. This device presents a moderate risk of adverse health consequences. Our evaluation indicates that your submitted recall plan is adequate.”

Press releases from Zimmer immediately follow, and never again do we hear about a mislabeled, mispackaged, or wrong sized product.

Suddenly it’s all about training doctors.

Page Twenty-Eight
“All monoblock metal-on-metal acetabular cups are recognized as technically challenging devices to implant.”

Page Twenty-Nine
“However, Zimmer does recognize this is a challenging procedure and thus is strongly recommending surgeons seek further training before attempting further Durom Cup implantations.”

If you have any questions or concerns about problems you or a loved one may have experienced with the Zimmer Durom Hip Replacement Cup, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com

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