NEXGEN® TRABECULAR METAL™ 00-5878-065-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024309821), received between May 28, 2020 and Jan 8, 2025 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Fracture; Fracture

  IT WAS REPORTED THE PATELLA WAS FOUND FRACTURED AT A POST SURGERY OFFICE VISIT. THERE IS A PLAN TO REVISE THE PATELLA BUT A DATE HAS NOT BEEN CONFIRMED.

  Patient problems: Failure of Implant

  MAUDE report 21102356 ↗
• InjuryOct 31, 2023Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO PAIN, SWELLING AND TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18039593 ↗
• InjuryMar 16, 2023Adverse 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: Bacterial Infection; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16553259 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN POST IMPLANTATION. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15418986 ↗
• InjurySep 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. SUBSEQUENTLY, THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE REVISED APPROXIMATELY 7 MONTHS LATER DUE TO POSSIBLE ASEPTIC LOOSENING. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15370472 ↗
• InjuryMay 28, 2020Adverse 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: Embolism

  MAUDE report 10098488 ↗