Zimmer CEO Boasts of Gains, US Patients Complain of Pains

About 350 components used as part of Zimmer NexGen knee replacements were quietly recalled last year because some were found to have nonconforming and inconsistent geometry. This, however, has not affected their bottom line, as a recent financial report on Zimmer saw them beating analyst’s predictions. CEO David Dvorak recently stated that, “Our results reflect improved sales execution in support of new product introductions across our diverse geographic channels, as well as the positive impact of operational improvement initiatives and continued disciplined capital deployment." Some see this as a move by the company to generate revenue from area’s where their reputation has not been hurt by the recalls issued against them.

In 2010, Zimmer quietly issued recalls for Zimmer NexGen knee replacement components that may have been used in thousands of individuals throughout the United States. Following reports of at least 114 Zimmer NexGen knee replacement problems, the manufacturer issued a recall for Zimmer NexGen MIS Tibial Components, NextGen TM

Zimmer Knee Study Doesn’t Look Good for Manufacturers

The Food and Drug Administration recently commissioned a study on the effectiveness of the FDA’s pre-market approval process for artificial joints such as the Zimmer NexGen and DePuy ASR and DePuy Pinnacle systems. The results of this study are about to be released – while, at the same time, proponents of the orthopedics industry are rushing to negate the impact of the results of the study before they are even published. It is likely that the study will recommend harsher regulations for the approval of new knee implant devices. The Food and Drug Administration is currently using a program that can “fast track” the medical device approval process, which has resulted in several products currently on the market which have a high rate of premature knee failure and other knee implant complications, including the Zimmer NexGen system.

The study, conducted by the Institute of Medicine, will likely have an impact on the way new medical devices are approved for use across the country. This could cut the risks for complications experienced by hundreds – even thousands – of patients, and will also likely reduce the number of patients having to undergo Zimmer knee revision surgery after experiencing knee implant failure. Knee revision surgery is a painful, complicated, and expensive procedure that is intended to fix problems associated with a knee implant failure in a patient.