With already about 5,000 complaints received by the US Food and Drug Administration (FDA) so far this year, the growing issue on metal-on-metal hip replacement is about to become the costliest and biggest medical device predicament ever. The Depuy hip replacement recall spawns thousands of complaints since it was announced last year. Accounting for 75 percent of complaints received by the FDA is the DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson (J&J).
Approximately a year ago, DePuy announced a worldwide recall of its ASR XL Acetabular System and Hip Resurfacing Platform after failing at a higher-than-expected rate. In the complaints, patients reported having symptoms such as:
• Pain around the hip joint
• Difficulty walking
• Swelling around the implant area
• Rash that is a sign of dying tissue
Those symptoms may be an indication of more severe problems such as:
• Dislocation, where the two parts of the implant that move against each other are no longer aligned. This happens because tissue around the joint becomes inflamed and weakened, and can’t hold it in place.
• Damage to the nerves, tissues and muscles near the implant area
• Fracture, where the bone around the implant may have broken.
• Loosening, when the implant does not stay attached to the bone in the right position.
Patients with metal-on-metal implants have numbered to 500,000 with hip replacements being one of the most common procedures in the U.S. Some 93,000 patients worldwide is using the ASR, according to DePuy. A New York Times analysis suggested that DePuy’s recall of its two hip systems could cost the company a billion dollars. Other hip makers aside from DePuy which were targets in a May FDA probe are Biomet Inc. and Zimmer Holdings Inc.
To administer patient claims for out-of-pocket medical costs associated with the recall, DePuy, which according to a Reuter report is facing more than 2,000 lawsuits in state and federal court in the United States, has hired the services of Broadspire Services Inc. Broadspire Services Inc. manages workers compensation and other medical claims on behalf of insurance companies and employers. However, the move was highly criticized as an act to save J&J and DePuy money.
The hip replacement recall is touted to be bigger than the Medtronic recall of its Sprint Fidelis lead in 2007 after the number of complaints on hip replacement this year so far went higher than the combined number of complaints received in the past four years.