Major orthopedic implant makers are getting behind a project aimed at tracking hip and knee implants in 90 percent of U.S. hospitals, hoping to get ahead of the recall curve.
The American Academy of Orthopaedic Surgeons created the non-profit American Joint Replacement Registry last year, incorporating in Illinois to take advantage of that state’s strong data-protection laws. It’s set to being collecting data from 15 hospitals this month, aiming to “assess the diversity of systems in place and discover the best methods of transmitting secure data,” according to the AJRR (PDF).
The orthopedics industry has also signed on, with companies including Biomet Inc., Johnson & Johnson’s (NYSE:JNJ) DePuy Orthopaedics division, Aesculap Inc., DJO Surgical, Wright Medical Group Inc. (NYSE:WMGI), Zimmer Holdings Inc. (NYSE:ZMH) and Exactech Inc. (NSDQ:EXAC) getting on board.
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But their participation doesn’t come without some trepidation about how problems revealed by the registry might affect business and concerns about protecting patient data. On the other hand, the registry could help identify problems earlier, allowing companies to take action to fix issues before they balloon into full-blown recalls.
Take Johnson & Johnson’s DePuy subsidiary, which recalled its ASR XL Acetabular and ASR Hip Resurfacing systems in August after a British registry turned up revision rates of 12 percent and 13 percent, respectively. Lawsuits began piling up even before the recall became official, with some plaintiffs alleging that the company knew of the problems with the implants. DePuy had discontinued the cup and phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a “higher-than-expected” failure rate in traditional hip replacements, especially in smaller patients or those with weak bones.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
