Shoulder Innovations TSA 24 mm x 5°Recalls & reported problems
Shoulder Innovations, Inc. · Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 24mm x 5°, UHMWPE · 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 B1132N2AI240050), received between Jan 22, 2026 and Jan 22, 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
- Muscle/Tendon Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
APPROXIMATELY 5 MONTHS AFTER THE PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH PROGRESSIVE PAIN, WEAKNESS AND LOSS OF FUNCTION. ADVANCED IMAGING AND CLINICAL EXAMINATION DEMOSTRATED A FAILURE OF THE SUBSCAPULARIS TENDON RESULTING IN ANTERIOR INSTABLITY AND LOSS OF BALANCED SHOULDER MECHANICS. THE HUMERAL AND GLENOID COMPONENTS THEMSELVES DID NOT SHOW ANY SIGNS OF MECHANICAL FAILURE, LOOSENING OR MALPOSITION, THERE WAS NO ISSUE WITH THE IMPLANTS. THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE SUBSSCAPULARIS TENDON FAILURE. THE PATIENT UNDERWENT A SUCCESSFUL CONVERSION TO A REVERSE TOTAL SHOULDER ARTHROPLASTY, DURING WHICH IT WAS CONFIRMED THAT THE SUBSCAPULARIS TENDON WAS DEFICIENT AND NONFUNCTIONAL AS PER THE PREOPERATIVE FINDINGS. THE PATIENT TOLERATED THE SURGER WELL WITHOUT COMPLICATIONS AND THE REVERSE TOTAL SHOULDER ARTHROPLASTY WAS NOTED TO BE STABLE, WELL-ALIGNED AND FUNCTIONING AS INTENDED.
Patient problems: Muscle/Tendon Damage
MAUDE report 24143806 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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