Regenerex 141357Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304554429), received between May 4, 2020 and Apr 7, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

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.

• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21784211 ↗
• InjuryOct 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

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

  MAUDE report 20343300 ↗
• InjuryJun 12, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. PATIENT HAD A KNEE ASPIRATION AND STERIOD INJECTION DUE TO PAIN AND SWELLING AND THAT PT LATER WAS DIAGNOSED WITH PATELLAR TENDONITIES. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN AND AMBULATION DIFFICULTIES, AND PATELLA PROSTHESIS FRACTURE WAS NOTED ON XRAY. PATIENT WAS REVISED APPROXIMATELY EIGHT YEARS POST-IMPLANTATION. DURING THE REVISION, BLACKENED SYNOVITIS AND MECHANICAL LOOSENING OF THE PATELLA WERE NOTED. ALL OTHER COMPONENTS WERE FOUND TO BE INTACT AND REMAINED IMPLANTED. NO FURTHER ADVERSE EVENTS WERE REPORTED.

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

  MAUDE report 19518838 ↗
• InjuryNov 17, 2022Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO PAIN, SWELLING AND FRACTURE OF PATELLAR COMPONENT. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Necrosis; Pain

  MAUDE report 15820711 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION OF THE PATELLA DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 10021885 ↗