TRABECULAR METAL® 00-5450-017-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024308381), received between Aug 26, 2020 and Apr 27, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION DUE TO FEMORAL IMPLANT LOOSENING. THE PATIENT WAS CONVERTED TO A SEGMENTAL FEMORAL SYSTEM DUE TO SEVERE BONE LOSS. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25005918 ↗
• 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 23933331 ↗
• InjuryAug 14, 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

  MAUDE report 19980904 ↗
• 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 17745664 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION. TWO YEARS AFTER THE MOST RECENT REVISION, THE PATIENT PRESENTED WITH PAIN OVER THE PES ANSERINE BURSA, SWELLING, STIFFNESS, AND A DECREASE IN FLEXION. LABS AND A BONE SCAN WERE ORDERED, BUT NO FURTHER INFORMATION OR REPORT OF INTERVENTION HAS BEEN PROVIDED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13506226 ↗
• InjuryNov 24, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED SHE HAS BEEN ENCOUNTERING PAIN, SWELLING, INFLAMMATION, AND DIFFICULTY WALKING AND EXERCISING SINCE HER REVISION SURGERY. SHE ALSO STATED SHE HAD A METAL ALLERGY TEST DONE, WHICH DETERMINED SHE IS HIGHLY ALLERGIC TO NICKEL AND COBALT CHROMIUM.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Reaction; Swelling

  MAUDE report 10895604 ↗
• InjuryAug 26, 2020Loosening 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

  MAUDE report 10456648 ↗