Shoulder Innovations Inset Reverse Total Shoulder Offset Glenosphere 36mm x 0mm x +3mmRecalls & reported problems
Shoulder Innovations, Inc. · Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +3mm. · 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 B1132R1GLC03360), received between May 11, 2026 and May 11, 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
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A SUCCESSFUL REVERSE TOTAL SHOULDER ARTHROPLASTY. AT THE CLINIC VISIT TWO WEEK POST PROCEDURE THE SURGEON NOTED THAT THE INCISION WAS HEALING WELL, THERE WAS SOME MILD ECCHYMOSIS AND SWELLING AND THE PROSTHESIS WAS PALPABLE ANTERIORLY. X-RAY IMAGING REVEALED THAT THE GLENOSPHERE HAD DISSOCIATED FROM THE BASEPLATE AND THE SURGEON DETERMINED THE PATIENT WOULD REQUIRE SURGICAL INTERVENTION TO ADDRESS THIS ISSUE. THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH THE GLENOID COMPONENTS WERE EXPLANTED AND REPLACED. THE PATIENT REPORTED NO ISSUES AND IMAGING DID NOT FIND ANYTHING ABNORMAL A CLINIC VISITS TWO WEEKS, ONE MONTH, THREE MONTHS AND SIX MONTHS FOLLOWING THE REVISION SURGERY. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.
Patient problems: Joint Dislocation
MAUDE report 25142880 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page