Comprehensive® Reverse Shoulder 115399Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Comprehensive Reverse Shoulder (57)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304677111), received between Apr 28, 2022 and May 12, 2026 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Expulsion” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Expulsion2
- Fracture2
- Loosening of Implant Not Related to Bone-Ingrowth1
- Malposition of Device1
- Migration1
- Packaging Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Erosion2
- Failure of Implant2
- Crepitus1
- Medical device site infection1
- Osteopenia/ Osteoporosis1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2026Malposition of Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Crepitus
MAUDE report 25150485 ↗MalfunctionJan 2, 2026Packaging Problem
IT WAS REPORTED THAT THE PEEL PACK OF THE STERILE DEVICE WAS COMPLETELY UNSEALED INSIDE OF A SEALED AND WRAPPED BOX. THE IMPLANT WAS RETURNED IN THE PEEL PACKAGING EXACTLY AS IT WAS REMOVED FROM OUTER BOX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN ANTERNATE DEVICE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945770 ↗InjuryOct 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions
MAUDE report 23321509 ↗InjuryMay 9, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT THE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO GLENOSPHERE DISSOCIATING FROM THE VRS AND THE CENTRAL SCREW LOOSE OR BACKING OUT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21993762 ↗InjuryJun 20, 2024Expulsion; Expulsion
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER ADAPTER FROM THE VRS COMPONENT. DURING THE REVISION, THE VRS COMPONENT REMAINED IMPLANTED WHILE THE TAPER ADAPTER WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Erosion
MAUDE report 19573769 ↗InjuryMay 2, 2024Expulsion; Expulsion
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Erosion; Osteopenia/ Osteoporosis; Pain
MAUDE report 19228200 ↗InjuryApr 28, 2022Fracture; Unintended Movement; Fracture; Unintended Movement
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 MONTHS POSTIMPLANTATION DUE TO IMPINGEMENT OF THE HUMERAL BEARING AND CUSTOM GLENOID. GLENOSPHERE AND VRS WERE REMOVED AND THE TRAY AND BEARING SWAPPED WITH A VERSADIAL HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 14239496 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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