Shoulder Innovations InSet 95 Humeral Stem 6x95mmRecalls & reported problems
Shoulder Innovations, Inc. · Shoulder Innovations - InSet 95 Humeral Stem - 6x95mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B1132L1S0600010), received between Mar 16, 2026 and Apr 10, 2026 — classified as 2 injuries.
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 Problem2
Patient problems
- Bone Fracture(s)1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A SUCCESSFUL TOTAL SHOULDER ARTHROPLASTY PROCEDURE. AT THE SIX MONTH POST PROCEDURE CLINIC VISIT, IT WAS STATED THAT THE PATIENT HAD SYMPTOMS SUGGESTIVE A METAL ALLERGY, NO OTHER DETAILS WERE PROVIDED. THE PATIENT SUBSEQUENTLY HAD AN ALLERGY TEST AND THE RESULTS FOUND THE PATIENT TO BE "MILDLY REACTIVE" TO CHROMIUM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24840969 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, THE PATIENT SUFFERED A CALCAR FRACTURE WHILE PLACING THE HUMERAL STEM. THE FRACTURE WAS REPAIRED USING CERCIAGE AND THE PROXIMAL CALCAR TENSIONED WITH SUTURETAPE. THERE WAS NO MALFUNCTION OF THE STEM BUT THE SURGEON DID RELATE THE FRACTURE TO THE DEVICE. THE SUREGON WILL FOLLOW UP REGARDING THE FRACTURE WITH X-RAYS AT CLINIC VISITS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 24610304 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented devices
- COMPREHENSIVE SHOULDER SYSTEM 113629Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall2 reports
- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- BIO-MODULAR SHOULDER SYSTEM 113865Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114648Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113863Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113867Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 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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