Regenerex 141358Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304506084), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 17, 2020Class IITerminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2146-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Fracture; Biocompatibility; Fracture; Biocompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SIX (6) YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY OF THE PATELLA COMPONENT AS ALL THREE PEGS ON THE DEVICE FRACTURED OFF. DURING THE REVISION SURGERY, A SIGNIFICANT AMOUNT OF BLACKENED SYNOVITIS DUE TO METALLOSIS WAS NOTED AND A SYNOVECTOMY WAS PERFORMED. THE PATELLA COMPONENT WAS REVISED HOWEVER ALL OTHER COMPONENTS REMAIN IMPLANTED AS NO ISSUES WERE NOTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Pain; Synovitis

  MAUDE report 16700847 ↗