Shoulder Innovations Inset Reverse Total Shoulder Offset Glenosphere 36mm x 0mm x +6mmRecalls & reported problems
Shoulder Innovations, Inc. · Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +6mm. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B1132R1GLC06360), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 injury.
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 Problem1
Patient problems
- Loss of Range of Motion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUCCESSFUL REVERSE SHOULDER ARTHROPLASTY AND THERE WERE NO ISSUES NOTED AT THE FIRST CLINIC VISIT TWO WEEKS POST PROCEDURE. AT THE SECOND CLINIC VISIT, APPROXIMATELY SIX WEEKS POST PROCEDURE, THE PATIENT WAS FOUND TO HAVE CAPSULITIS WITH RANGE OF MOTION SCORES REDUCED FROM THE PRE-OPERTATIVE EVALUATION. MEDICAL INTERVENTION WAS PERFORMED, THE DETAILS WERE NOT PROVIDED. THE SURGEON DID NOT RELATED THE EVENT TO THE DEVICE AND THERE WAS NO ALLEGATION THAT THE IMPLANT HAD MALFUNCTIONED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Loss of Range of Motion
MAUDE report 24604671 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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