Shoulder Innovations Inset Reverse Total Shoulder RSA Constrained Humeral Bearing: 33mm x 0mm x 5Recalls & reported problems
Shoulder Innovations, Inc. · Shoulder Innovations Inset Reverse Total Shoulder - Constrained Humeral Bearing - 33mm Diameter, +0 mm Lat, 5 degree · 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 B1132R1P1505330), received between Jun 8, 2026 and Jun 8, 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
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD "ADVANCED OSTEOARTHRITIS" AND WAS TO UNDERGO A REVERSE TOTAL SHOULDER ARTHROPLASTY. WHEN ACCESSING THE SHOULDER IT WAS FOUND THAT THE PATIENT HAD A HIGHLY ATTENUATED SUBSCAPULARIS IN A VERY DISEASED BICEPS TENDON. THE SUBSCAPULARIS WAS CAREFULLY REMOVED FROM THE LOWER TUBEROSITY AND THE PROXIMAL HUMERUS EXPOSED AND EXAMINED. PERIPERAL OSTEOPHYTES WERE REMOVED. FOLLOWING OSTEOTOMY, GROSS OSTEOPOROSIS AND POOR BONE QUALITY WERE NOTED. A ROXIMAL HUMERAL PROTECTOR WAS "GENTLY" PUT ON THE PROXIMAL HUMERUS AND THEN RELOCATED IN THE WOUND AND RETRACTED POSTERIORLY. HOWEVER, AS SOON AS THE SURGEON RETRACTED, THERE WAS A FRACTURE OF BOTH THE GREATER AND LESSER TUBEROSITIES. PATIENT WAS TREATED WITH CERCLAGE SUTURES AROUND THE PROXIMAL HUMERUS DURING SURGERY.THE SURGEON DID NOT RELATE THE FRACTURES TO THE DEVICE BUT DID RELATE IT TO THE SURGICAL PROCEDURE. DUE TO THE COMPLEXITIES OF THE CASE AND THE PATIENT'S POOR BONE QUALITY THE PATIENT WAS UNDER ANESTHESIA FOR AN ADDITIONAL PERIOD. THERE WAS NO OTHER CLINCIAL CONSEQUENCE TO THE PATIENT.
Patient problems: Bone Fracture(s)
MAUDE report 25435403 ↗
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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