Artificial joint implants made by Zimmer Holdings are the subject of a probe by Senator Charles Grassley (R-Iowa). Grassley, the ranking Republican on the Senate Finance Committee, wrote to Zimmer last week seeking information on its handling of complaints relating to those devices. The senator is also seeking information on how Zimmer tracks the long-term performance of its artificial knees and hips.
Grassley’s new investigation was prompted by disputes between Zimmer and two of its consultants that had been reported by The New York Times. In one case, Dr. Richard A. Berger alleged Zimmer ended its long-term relationship with him after he reported problems with Zimmer’s NexGen CR-Flex Porous Femoral Component.
In another case, Dr. Lawrence Dorr of Los Angeles alerted other orthopedic surgeons two years ago that a component known as the Durom cup was failing in patients soon after implant, requiring costly and painful replacement surgery. Zimmer blamed the problem’s on Dorr’s surgical technique, and a Food & Drug Administration investigation into the Durom cup was closed after the company presented data from 12 surgical centers showing that the hip was working well.
In June, two other surgeons who supplied that data to Zimmer told the Times that they had problems with early failure of the Durom cup, and no longer believed it was due to surgical technique.
Now, according to The New York Times, Grassley is asking Zimmer to supply a list of the safety concerns raised in the last two years by its outside consultants, and details on how it responded to such concerns. Saying he was “troubled” by the recent revelations made by the Times, Grassley asked for a detailed response from Zimmer by August 12.
In its own statement, Zimmer said it welcomed the opportunity to answer Grassley’s questions.
