Trabecular Metal® 00-7864-012-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024139237), received between Sep 1, 2021 and Mar 14, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K051491); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2023Packaging Problem; Packaging Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536436 ↗
• InjurySep 1, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE, SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO DISSOCIATE THE TRUNNION ADAPTER SLEEVE FROM THE FEMORAL COMPONENT RESULTING IN A SMALL FRACTURE OF THE GREATER TROCHANTER. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS PERFORMED TO REMOVE THE STEM. A NEW STEM WAS PLACED WITHOUT COMPLICATION, AND THE FRACTURES WERE SECURED WITH A PLATE AND CABLES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 12406070 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051491. One submission often covers many models, so check the product and lot details in each record.

• Z-0939-2018 · Jan 3, 2018 · Terminated
  Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17)
• Z-0366-2012 · Nov 16, 2011 · Terminated
  Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY - STANDARD NECK OFFSET
• Z-1473-06 · Aug 2, 2006 · Terminated
  Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -standard neck offset, size 16, 171 mm stem length, sterile, ti
• Z-1471-06 · Aug 2, 2006 · Terminated
  Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 14, 149 mm stem length, sterile, ti
• Z-1472-06 · Aug 2, 2006 · Terminated
  Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm stem length, sterile, ti