TRABECULAR METAL® 00-5450-013-36Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024308275), received between Mar 18, 2025 and Aug 22, 2025 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Ambulation or Postural Difficulties2
- Erythema2
- Pain2
- Swelling/ Edema2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS AND FOUR (4) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN EXPERIENCING SWELLING, PAIN, STIFFNESS, INSTABILITY, BUCKLING, REDNESS, DIFFICULTY WALKING, AND A CRACKING SOUND/LOUD PAINFUL POPS. DIAGNOSTIC IMAGING WAS PERFORMED AND DID NOT REVEAL LOOSENING OF THE CEMENTED COMPONENTS. ALL IMPLANTS REMAIN IMPLANTED AND ADDITIONAL MEDICAL INTERVENTION HAS NOT BEEN REPORTED.
Patient problems: Ambulation or Postural Difficulties; Erythema; Pain; Swelling/ Edema
MAUDE report 22872485 ↗InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS AND FOUR (4) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN EXPERIENCING SWELLING, PAIN, STIFFNESS, INSTABILITY, BUCKLING, REDNESS, DIFFICULTY WALKING, AND A CRACKING SOUND/LOUD PAINFUL POPS. DIAGNOSTIC IMAGING WAS PERFORMED AND DID NOT REVEAL LOOSENING OF THE CEMENTED COMPONENTS. ALL IMPLANTS REMAIN IMPLANTED AND ADDITIONAL MEDICAL INTERVENTION HAS NOT BEEN REPORTED.
Patient problems: Ambulation or Postural Difficulties; Erythema; Pain; Swelling/ Edema
MAUDE report 21632140 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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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