NEXGEN® TRABECULAR METAL® 00-5878-065-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024465664), received between Jun 27, 2019 and Feb 20, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

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.

• InjuryFeb 20, 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: Bone Fracture(s)

  MAUDE report 21420466 ↗
• InjuryAug 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AND TWO WEEKS POST IMPLANTATION DUE TO UNKNOWN REASONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15198759 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A MANIPULATION, UNDER ANESTHESIA OF THE RIGHT KNEE TWO MONTHS POST PROCEDURE, DUE TO ARTHROFIBROSIS OF THE JOINT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT DEMONSTRATED OVERALL IMPROVEMENT WITH PAIN, SATISFACTION, AND QUALITY OF LIFE AND COMPLETED THE STUDY PER PROTOCOL WITH NO FURTHER INTERVENTIONS.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 14498747 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT 6 MONTHS POST IMPLANTATION. THERE HAS BEEN NO REPORT OF MEDICAL INTERVENTION OR REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 8739133 ↗