TRABECULAR METAL® 00-5450-013-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024308299), received between Feb 28, 2019 and Jun 6, 2022 — classified as 3 injuries.

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

• InjuryJun 6, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TKA WITH DR (B)(6) -STANDARD PRIMARY WITH CONE. SCREW BELOW IMPLANT THAT COULDN¿T BE REMOVED SO NO STEM USED. PATIENT HAD BECOME VERY UNSTABLE LATERALLY SO CAME FOR REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ONCE OPENED UP WE FOUND POLY HAD BE SMASHED ON THE POSTERIOR MEDIAL CORNER. IT WAS HYPOTHESISED THAT MAYBE THE TIBIAL TRAY WAS KICKED INTO TOO MUCH EXTERNAL ROTATION WHICH CAUSED THE FEMUR TO CONTACT MORE POSTERIOR AND THE PATIENT MAY HAVE SUBLUXED POSTEROMEDIALLY. THERE WAS METALOSSIS IN THE JOINT FROM THE FEMUR RUBBING ON THE TIBIAL COMPONENT AS SEEN IN THE ATTACHED PICTURE OF EXPLANTED TIBIA. CONE WAS REMOVED AS WE COULDN¿T FIX ROTATION. COMPETITOR PRODUCT PERIMETER CONE USED WITH PRIMARY BASEPLATE AND STUBBY STEM AND ROTATION WAS CHANGED TO IMPROVE CONTACT POINT.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 14604239 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT EXPERIENCED STREP G INFECTION SUBSEQUENT TO CELLULITIS WHICH BEGAN APPROXIMATELY FOUR MONTHS POST-IMPLANTATION. PATIENT UNDERWENT A WASHOUT PROCEDURE WITH THE POLYETHYLENE BEARING EXCHANGED. THE INFECTION CONTINUED AND THE PATIENT UNDERWENT AN ARTHROSCOPIC WASHOUT PROCEDURE APPROXIMATELY ONE MONTH LATER. STILL, THE INFECTION CONTINUED; THEREFORE, THE PATIENT UNDERWENT LONG-TERM ANTIBIOTIC THERAPY UTILIZING VANCOMYCIN WITH NO RESOLUTION OF THE INFECTION. THE PATIENT SUBSEQUENTLY UNDERWENT A WASHOUT PROCEDURE WITH REVISION OF ALL IMPLANTS AND WAS IMPLANTED WITH ANTIBIOTIC CEMENT SPACERS.

  Patient problems: Unspecified Infection

  MAUDE report 8413125 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS STREP G INFECTION OF RIGHT LCCK KNEE REPLACEMENT SUBSEQUENT TO CELLULITIS OF THE OPERATIVE LEG WHICH DEVELOPED IN (B)(6) 2017. WASHOUT AND LINER CHANGE (B)(4) LOT 62727436 IMPLANTED (B)(6) 2017. ARTHROSCOPIC WASHOUT REPEATED (B)(6) 2017. LONG TERM ANTIBIOTIC THERAPY HAS SEEN NO RESOLUTION OF INFECTION. NOTIFIED AT 1930HRS (B)(6) 2019 BY PHONE BY (B)(6) OF DECISION TO REMOVE LCCK AND TIBIAL CONE, WASHOUT AND REPLACE WITH CEMENT SPACERS. TM TIBIAL CONE IS THE TMT DESIGN CONTROLLED PART.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 8379295 ↗