Trabecular Metal® 00-7864-018-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024139350), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THE PRODUCT PACKAGING WAS COMPROMISED. THE SEAL WAS REPORTED TO BE BROKEN BY THE IMPLANT BREAKING OR CRACKING THE STERILE PACKAGING FROM THE INSIDE. THERE ARE NO VISIBLE SIGNS OF DAMAGE IN EITHER DIRECTION OF INTERNAL PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140618 ↗

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-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
• 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-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