Trabecular Metal® 00-4501-040-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024270459), received between Jan 20, 2021 and Mar 15, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K120906); they may or may not involve this specific model.

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.

• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 13775451 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS PERFORMED WITH TM ANKLE SYSTEM. APPROXIMATELY FOUR MONTHS POST-PROCEDURE, WHILE THE PATIENT WAS WALKING, THEY EXPERIENCED A SHOCK IN THE RIGHT LEG AND HAD A FRACTURE OF THE TIBIAL DIAPHYSIS WHERE THE PIN WAS INSERTED. NO REVISION HAS BEEN REPORTED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 13775441 ↗
• MalfunctionJan 20, 2021Unsealed Device Packaging; Unsealed Device Packaging

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11201004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120906. One submission often covers many models, so check the product and lot details in each record.

• Z-0306-2020 · Oct 10, 2019 · Terminated
  TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 0045000250
• Z-0477-2014 · Nov 12, 2013 · Terminated
  Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reduci
• Z-0476-2014 · Nov 12, 2013 · Terminated
  Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducin
• Z-0475-2014 · Nov 12, 2013 · Terminated
  Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing