Trabecular Metal® 00-7864-013-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024139268), received between Oct 13, 2022 and Aug 13, 2025 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED A CORTISONE INJECTION FOR TROCHANTERIC BURSITIS APPROXIMATELY FOUR YEARS AFTER IMPLANTATION. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Bursitis

  MAUDE report 22798004 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Bursitis; Discomfort

  MAUDE report 20833369 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Bursitis; Pain; Unequal Limb Length

  MAUDE report 20833338 ↗
• InjuryFeb 2, 2023Adverse 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 APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO A POST-OP HEMATOMA AND DRAINING SINUS. THIS REQUIRED AN INCISION, DRAINAGE, ANTIBIOTICS AND JOINT DEBRIDEMENT. CONCLUDING THIS PROCEDURE, AN UNSPECIFIED INFECTION WAS NOTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Hematoma; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 16284948 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP JOINT DEBRIDEMENT APPROXIMATELY TWO WEEKS POST IMPLANTATION DUE TO EXCESSIVE DRAINAGE AND HEMATOMA. SUBSEQUENTLY, FIVE WEEKS POST-OP, THE PATIENT EXPERIENCED DELAYED HEALING OF THE LEFT TOTAL HIP ARTHROPLASTY WOUND. THE SURGEON UTILIZED THE PREVIOUS INCISION AND PERFORMED AN ARTHROTOMY. THE INCISION WAS ENTIRELY INTACT EXCEPT FOR A PIN HOLE AT THE CENTRAL PORTION. ONCE THE PIN HOLE WAS DISSECTED, THE SURGEON ENCOUNTERED A FLUID COLLECTION IN THE SUBCUTANEOUS REGION WITH A SMALL AMOUNT OF FATTY NECROSIS AND THE PRESENCE OF SEROUS FLUID. THREE CULTURES WERE OBTAINED AND SENT TO PATHOLOGY. THE WOUND WAS IRRIGATED AND DEBRIDED, AND THERE WAS NO PURULENCE OR EVIDENCE OF FRANK INFECTION PRESENT. A FORMAL ARTHROTOMY WAS THEN PERFORMED TO ENSURE ADEQUATE IRRIGATION AND DEBRIDEMENT WITH INTACT IMPLANTS NOTED. THE SURGEON REPORTED THAT THE EVENT WAS PROBABLY RELATED TO PROCEDURE; NOT RELATED TO DEVICE AND OR INSTRUMENTS. THE PATIENT HAD BEEN RECEIVING ROCEPHIN BUT WAS SWITCHED TO IV DAPTOMYCIN DUE TO RASH FROM ROCEPHIN. APPROXIMATELY ONE WEEK POST ARTHROTOMY, THE PATIENT WAS EVALUATED AT THE ER FOR DYSPNEA, TACHYCARDIA AND LEFT LEG PAIN. A

  Patient problems: Hematoma; Pulmonary Embolism; Unspecified Infection

  MAUDE report 16272609 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT NEEDED A CORTISONE INJECTION APPROXIMATELY 1-YEAR POST IMPLANTATION FOR TROCHANTERIC BURSITIS. NO ADDITIONAL INFORMATION ON THE REPORTED IS UNAVAILABLE AT THIS TIME.

  Patient problems: Inflammation

  MAUDE report 15598938 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT NEEDED A CORTISONE INJECTION APPROXIMATELY 1-YEAR POST IMPLANTATION FOR TROCHANTERIC BURSITIS. NO ADDITIONAL INFORMATION ON THE REPORTED IS UNAVAILABLE AT THIS TIME.

  Patient problems: Inflammation

  MAUDE report 15598932 ↗

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-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