Trabecular Metal Reverse Plus™ 00-4362-015-00Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Trabecular Metal Reverse Plus (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024489431), received between Jun 26, 2020 and Dec 19, 2023 — classified as 7 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).
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
- Detachment of Device or Device Component5
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 18359445 ↗InjurySep 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17709889 ↗InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 MONTHS POSTIMPLANTATION DUE TO DISASSOCIATION. THE GLENOSPHERE AND POLY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 14278102 ↗InjuryApr 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 2 MONTHS POSTIMPLANTATION DUE TO DISASSOCIATION OF THE BASEPLATE AND GLENOSPHERE. THE GLENOSPHERE WAS REPLACED WITH A SMALLER SIZE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 14166925 ↗InjuryApr 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 1 MONTH POSTIMPLANTATION DUE TO DISASSOCIATION OF THE BASEPLATE AND GLENOSPHERE. BOTH DEVICES WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 14166919 ↗InjuryFeb 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SHOULDER PROCEDURE APPROXIMATELY TWO (2) MONTHS POST IMPLANT DUE TO GLENOSPHERE DISSOCIATING FROM THE BASE PLATE. DURING PROCEDURE IT WAS NOTED THAT ONLY THE GLENOSPHERE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 11262903 ↗InjuryJun 26, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY FOUR (4) WEEKS AGO DUE TO A BROKEN SCREW AND LOOSE COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 10200886 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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