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The latter was the first surgical robot that was approved by the FDA in 2008. The ROBODOC from Integrated Surgical Systems (working closely with IBM) could mill out precise fittings in the femur for hip replacement.
The documentary explores the FDA's 510(k) process which allows a medical device to be fast-tracked onto the market with less clinical study and human testing. The film also explores problems with hip replacement devices that can lead to cobalt poisoning and vaginal mesh devices that injured multiple women.
Hip replacement is one of the most common orthopaedic operations, though patient satisfaction varies widely. Approximately 58% of total hip replacements are estimated to last 25 years. The average cost of a total hip replacement in 2012 was $40,364 in the United States, and about $7,700 to $12,000 in most European countries.
The recent FDA go-ahead for Zimmer Biomet's (ZBH) ROSA Hip System will aid surgeons perform robotically-assisted direct anterior total hip replacement surgery.
In 2006, the United States FDA approved hip resurfacing using the Birmingham Hip Resurfacing (BHR) system, designed by British Orthopaedic surgeon Derek McMinn. All other FDA approved devices have been removed from the US Market. The BHR is no longer suggested for use in women.
The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson and Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010.