Regenerex 141356Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304554412), received between Dec 9, 2020 and Jun 17, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 reports).

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 16, 2026.

Recalls naming this device

1. Apr 17, 2020Terminated

   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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA THE LEGAL DEPARTMENT THAT A PATIENT HAD AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY EIGHT YEARS LATER, THE PATIENT WAS REVISED DUE TO PATELLAR IMPLANT FRACTURE AND LOOSENING. DURING THE REVISION, TWO OF THE THREE PEGS ON THE PATELLA PROSTHESIS WERE FOUND TO BE BROKEN. THE PATELLA IMPLANT WAS REMOVED AND REPLACED WITH COMPETITOR PRODUCT. THERE WERE NO CONCERNS WITH THE REMAINING IMPLANTS AND NO INTRAOPERATIVE COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 19546891 ↗
• InjuryApr 22, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Metal Related Pathology; Necrosis; Pain

  MAUDE report 11709023 ↗
• InjuryApr 20, 2021Fracture; Patient Device Interaction Problem; Fracture; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain; Scar Tissue

  MAUDE report 11692385 ↗
• InjuryMar 11, 2021Loss of or Failure to Bond; Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY FIVE YEARS¿ POST-IMPLANTATION DUE TO PAIN, IMPLANT FRACTURE, SCAR TISSUE, AND LOOSENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Scar Tissue

  MAUDE report 11464660 ↗
• MalfunctionDec 9, 2020Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION NEARLY FIVE YEARS POST-IMPLANTATION DUE TO PATELLA IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 10976524 ↗