Risk of Recall for Total Joint Arthroplasty Devices Over 10 Years

Area of Science:

• Orthopaedic surgery
• Medical device regulation
• Biomedical engineering

Background:

• Orthopaedic devices represent nearly 20% of medical devices, with 12-20% recalled within 10 years.
• Over 95% of these devices are approved via the Food and Drug Administration's 510(k) pathway without clinical data.
• The recall risk for orthopaedic arthroplasty devices specifically, approved through the 510(k) pathway, has not been previously studied.

Purpose of the Study:

• To investigate the recall risk of orthopaedic arthroplasty devices approved through the Food and Drug Administration's 510(k) pathway.
• To compare the recall risk between hip and knee arthroplasty devices.
• To identify common reasons for arthroplasty device recalls.

Main Methods:

• Querying the Food and Drug Administration 510(k) database for orthopaedic devices approved between January 1, 2008, and December 31, 2018.
• Classifying devices into hip and knee arthroplasty using product codes.
• Analyzing recall data, including numbers, dates, and reasons, and employing cumulative incidence function to compare recall risks.

Main Results:

• A total of 904 arthroplasty devices were included: 485 hip (53.7%) and 419 knee (46.3%).
• Recall rates were 19.4% for hip and 20.3% for knee devices.
• The 10-year recall hazard was approximately 24% for both hip and knee arthroplasty devices, with no statistical difference. Process control (29.6%) and device design (26.3%) were the most frequent recall causes.

Conclusions:

• The recall risk for arthroplasty devices is higher than previously recognized.
• Enhanced postmarket surveillance strategies are crucial for patient safety.
• Increased physician involvement in detecting and reporting device safety issues is necessary.