TRABECULAR METAL™ 00-4894-050-10Recalls & reported problems
Zimmer Trabecular Metal Technology Inc. · Class 2 · Implant
All models of TRABECULAR METAL (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024306769), received between Sep 14, 2020 and Apr 14, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of or Failure to Bond1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Aseptic loosening1
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 16 MONTHS POST-IMPLANTATION DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 24875201 ↗InjuryAug 22, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. APPROXIMATELY TEN (10) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND THE ACETABULAR AUGMENT WAS FOUND TO BE FRACTURED. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE AFFECTED COMPONENT WITHOUT REPORTED COMPLICATION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE; ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 22873166 ↗MalfunctionAug 11, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22778767 ↗InjurySep 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, 2 YEARS 3 MONTHS POST PROCEDURE, PATIENT WAS REVISED DUE TO FIXATION FAILURE OF THE CUP. SALES REP INDICATES NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Code Available
MAUDE report 10528156 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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