TRABECULAR METAL® 00-5450-021-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024308466), received between Sep 14, 2023 and Dec 31, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY NINE (9) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN IN THE IMPLANTED JOINT. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPONENTS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23933422 ↗
• InjurySep 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR AND NINE MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN, INSTABILITY, IMMOBILITY AND MODERATE JOINT EFFUSION. DIAGNOSTIC IMAGES REVEALED THAT THE LOCKING BAR COMPONENT OF THE ARTICULAR SURFACE HAD FRACTURED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE SURGERY, THE KNEE JOINT WAS FOUND TO BE UNCOUPLED FROM THE CONNECTOR DUE TO BREAKAGE OF THE LOCKING BOLT AS WELL AS DORSAL DISLOCATION OF THE ARTICULAR SURFACE AND LOOSENING OF THE CEMENTED FEMORAL COMPONENT. THE FEMORAL COMPONENTS AND ARTICULAR SURFACE WERE REVISED WITHOUT COMPLICATION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE; ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation; Joint effusion; Pain

  MAUDE report 17745668 ↗