Not A Zimmer Durom Hip Recall But A Suspension of Sales
Much confusion has surrounded the issue of whether or not there was ever a recall of the Zimmer Durom Cup hip implant. This may be due in part to the 2008 Durom Cup “suspension of sales, ” an event that many legal firms have wrongly characterized as a Zimmer hip recall.
The events at the heart of the controversy are fairly straightforward. Zimmer Inc., one of the largest orthopedic device manufacturers in the world, temporarily suspended sales of the hip replacement component in 2008 after bowing to pressure from the demands of a prominent orthopedic surgeon who raised serious doubts about the model’s design and functionality. According to the doctor, high levels of hip implant failure and hip revision surgery were being reported among a disproportionately high number of recipients.
At the time, 12,000 hip recipients had already been fitted with the acetabular component in question – many of them presumably victims.
Zimmer Inc. withdrew the model, investigated the problems, revised surgical instructions and remarketed the device after a hiatus of just a couple months.
Suspension of sales is voluntary – A Zimmer Durom hip recall is not
The suspension of sales, Zimmer maintained, was voluntary. It was not a formal hip recall as interpreted by many.
The company’s suspension of sales did not constitute a recall, as defined by the FDA. The event did not, at the time, involve any violations that would have been subject to legal action by the FDA.
Upon a company decision to defend its hip implant, Zimmer reinstated sales of the product just as voluntarily as it suspended them. Whether the FDA would not have intervened had Zimmer continued to market the Durom Cup as it had prior to the investigation or with the former surgical instructions remains a moot point.
Is Zimmer Durom Cup defective?
Some doctors maintain, to this day, that the Durom Cup is, in itself, a defective product. At least one prominent surgeon recommended that a full Zimmer Durom hip recall take place when the company issued its temporary suspension of sales in 2008. But that full recall never happened.
To make good on the suspension of sales, Zimmer set aside nearly $100 million to compensate Durom Cup recipients who may have been fitted with the device before or after 2008. More than 12,000 Durom Cup recipients may be eligible to file a Zimmer hip lawsuit and receive a portion of the fund set aside by Zimmer. Dozens of patients have already contacted a Zimmer hip lawyer to file a lawsuit.