Friday, September 26, 2008

Zimmer Hip Cup Recall

Zimmer Holdings, the largest producer of orthopedic devices in the United States, recently halted sales of a hip replacement implant which has been failing in unacceptably high numbers. The Durom Cup hip socket implant, introduced by Zimmer in 2006, has been implanted in over 13,000 patients across the nation. Of those, doctors say that hundreds will most likely need to undergo more expensive and painful surgery to replace the replacement.

Over 5% of patients implanted with the Zimmer Durom Cup hip replacement experience serious problems, according to research conducted by the company and orthopedic surgeons. In these patients, the metal hip implant fails to bond properly with the existing bone structure. Instead, the metal socket loosens and separates, grinding painfully against bone as it moves.

Although Zimmer Holdings was alerted to problems with its Durom Cup hip replacement as early as 2007, it did not launch an investigation until April 2008, and did not cease its sales of the defective device until July 2008. Because of the company’s delay, even more unsuspecting patients were implanted with the faulty Durom Cup hip replacement. Each may need hip replacement surgery, which is a lengthy and expensive procedure, costing anywhere from $30,000 to $40,000.

The Zimmer Durom Cup Hip Implant – A Timeline

2006 – The Zimmer Durom Cup hip implant is introduced. A metal hip socket replacement originally designed for a 15- to 20-year lifespan to accommodate young, active patients, the Durom Cup implant begins to show signs of trouble not long after its debut.

2007 – Prominent orthopedic surgeon Dr. Lawrence Dorr, alerts Zimmer Holdings, the implant’s manufacturer, after noticing that the Zimmer hip replacement implant has an abnormally high failure rate. Dorr states that many of his patients return to his office complaining of extreme pain only months after undergoing hip replacement surgery. Despite Dorr’s extensive experience, Zimmer Holdings blames the implant failures on Dorr’s surgical technique and brushes the warning aside.

2008 – In April, Dr. Dorr goes public with his concerns, warning other orthopedic surgeons against using the Durom Cup hip implant. Zimmer responds by launching an investigation, but refuses to take any further action for months. In July 2008, after its own investigation reveals an implant failure rate of over 5%, Zimmer suspends sales of the device but promises to resume business after doctors are trained to ‘properly’ install the implant.