Examining Temporary Suspension of Durom Cup
In 2008, Zimmer Inc. temporarily suspended Zimmer Durom Cup sales after reports of early hip failure, that in several cases required hip revision surgery, got the attention of the device manufacturer. As a result, many of those patients subsequently contacted a Zimmer hip lawyer.
A suspension of sales means that the company voluntarily chose to stop selling the product for a brief period of time. Zimmer Inc. chose to suspend sales for three months while the company investigated the source of the complaints and reasons for the reports of Zimmer hip replacement failure.
FDA recall classifications
If the situation had warranted a Zimmer hip replacement recall, the Federal Drug Administration (FDA) would have classified the recall as Class I, Class II or Class III based on the risk to public health.
Had the Zimmer Durom Cup temporary suspension been a Class I Zimmer hip replacement recall, which is the highest recall classification, Zimmer Inc. would have had to notify its customers and recipients about the recall, the reason for the recall and measures to take to avoid or minimize the problems associated with the recall. The FDA only issues Class I recalls for products that “will cause serious health problems or death.”
A Class II FDA recall is less serious and is issued if there’s a possibility the device will cause serious health problems. With a Class II recall, the company must contact its customers but isn’t always required to contact device recipients.
A Class III FDA recall is a low risk recall that’s generally issued when a device isn’t likely to cause health problems but is in some way violative of FDA regulation.
A Zimmer hip lawyer is best equipped to give a thorough review of the differences between a company issued temporary suspension of sales and an FDA recall. An FDA issued Zimmer hip replacement recall could have resulted in many lawsuits but even without the recall, Zimmer Inc. is facing sizeable litigation.
Future of Zimmer hips
Though the Zimmer Durom Cup was not recalled, in February, the FDA recently issued a public announcement about metal-on-metal hip replacements like the Zimmer Durom Cup. In May, the FDA required 21 metal-on-metal manufacturers to participate in studies regarding the post-market performance of the devices. Zimmer Inc. was among the 21 listed.
Though the most recent FDA communications regarding metal-on-metal devices certainly isn’t an industry wide recall, it could feasibly lead to a Zimmer hip replacement recall or a recall of other metal-on-metal devices some time in the future. For now, the FDA continues to scrutinize the devices themselves as well as the procedures by which they gain FDA approval before getting released to consumers.