Regenerex 141355Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304554405), received between May 3, 2019 and Jul 22, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY. DURING AN OFFICE VISIT IT WAS NOTED THE PATIENTS PATELLA HAS FAILED. ALL 3 PEGS ARE OFF AND THE LOOSENESS OF PATELLA IS CAUSING HER PAIN. PATIENT HAS NOT UNDERWENT A REVISION PROCEDURE TO DATE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12214165 ↗
• InjuryAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY FOUR YEARS AGO. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE SIX MONTHS AGO FOR UNKNOWN REASONS.

  Patient problems: No Information

  MAUDE report 10374904 ↗
• InjuryAug 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO TWO FRACTURED PEGS ON THE PATELLA PROSTHESIS. THE PATELLA WAS REMOVED AND REPLACED.

  Patient problems: No Information

  MAUDE report 10372592 ↗
• InjuryMay 3, 2019Corroded; Fracture; Material Fragmentation; Corroded; Fracture; Material Fragmentation

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

  Patient problems: Discomfort; Failure of Implant; Metal Related Pathology; Pain; Swelling/ Edema; Synovitis

  MAUDE report 8577769 ↗