Trabecular Metal Reverse Plus™ 00-4362-020-00Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024489448), received between May 18, 2023 and Jan 8, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 Component3
- Adverse Event Without Identified Device or Use Problem2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant2
- Joint Dislocation2
- Bone Fracture(s)1
- Discomfort1
- Pain1
- Pneumonia1
- Pulmonary Embolism1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2026Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 24003838 ↗InjuryMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION AFTER COMPLAINING OF DISCOMFORT. PRIOR TO THE REVISION, AN X RAY REVEALED WHAT APPEARED TO BE A FRACTURED TAPER THAT HAD DISENGAGED FROM THE GLENOSPHERE. A NEW GLENOSPHERE, BEARING, AND BASEPLATE WERE IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Discomfort; Failure of Implant
MAUDE report 22001700 ↗InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT RETURNED TO CLINIC FOR EVALUATION DUE TO PAIN. IMAGING CONFIRMED A STRESS FRACTURE LATERAL TO THE GLENOID. PATIENT WORE A SLING FOR FOUR WEEKS TO IMMOBILIZE THE JOINT AND ALSO RECEIVED ADDITIONAL PHYSICAL THERAPY. THE EVENT WAS REPORTED TO BE RESOLVED. APPROXIMATELY ONE-YEAR POST-IMPLANTATION, THE PATIENT WAS NOTED TO HAVE SLIGHT PAIN AND SLIGHT DIFFICULTY WITH ACTIVITIES. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. DUE DILIGENCE IS PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Bone Fracture(s); Pain
MAUDE report 21531871 ↗InjuryFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 21300089 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY A MONTH AGO. SUBSEQUENTLY, 2 DAYS LATER THE PATIENT DEVELOPED PNEUMONIA AND PULMONARY EMBOLISM. MEDICAL TREATMENT INCLUDED ANTIBIOTICS, ANTICOAGULANTS, AND OXYGEN. THE ISSUE WAS RESOLVED 13 DAYS LATER. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Pneumonia; Pulmonary Embolism
MAUDE report 18902590 ↗InjuryMay 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY TWO (2) WEEKS POST IMPLANTATION DUE POOR BONE QUALITY, DISLOCATION, AND FIXATION OF IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16959211 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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