Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023

Area of Science:

• Orthopaedic Surgery
• Medical Device Safety
• Regulatory Science

Background:

• Orthopaedic devices represent a significant portion of medical devices, with a notable percentage facing recalls within a decade of FDA clearance.
• Class I recalls, indicating potential for serious injury or death, are the FDA's highest concern but have not been systematically analyzed for orthopaedic devices.
• Concerns exist regarding the timeliness of responses to safety signals for orthopaedic implants.

Purpose of the Study:

• To systematically characterize Class I recalls of orthopaedic devices.
• To analyze recall causes, authorization pathways, and time intervals between adverse event reports and formal recalls.
• To identify areas for improvement in postmarket surveillance of orthopaedic implants.

Main Methods:

• Review of the FDA recall database for Class I orthopaedic device recalls (November 2002 - December 2023).
• Categorization of devices by subspecialty, authorization pathway (510(k) vs. PMA), and recall cause.
• Reclassification of FDA root causes and calculation of the interval between earliest Adverse Event Reports (AERs) and recall.

Main Results:

• Sixteen Class I recall events impacted 20 orthopaedic devices, predominantly in arthroplasty (50%) and spine (44%).
• Most recalled devices (87%) were cleared via the 510(k) pathway, with design flaws cited in 69% of recalls.
• A significant delay was observed between the earliest AER and recall, with a median of 5.8 years for arthroplasty versus 1.8 years for spine devices.

Conclusions:

• Class I orthopaedic recalls frequently involve design flaws in 510(k)-cleared devices, with substantial delays in recall initiation, particularly for arthroplasty implants.
• Discrepancies between FDA classifications and clinical judgment, alongside inconsistent recall labeling, necessitate improved postmarket surveillance.
• Enhanced surveillance should involve surgeon collaboration and integration with existing registries to enable earlier detection of problematic orthopaedic devices.