SMR Shoulder Cemented Glenoid (REF 1379.50.030)Recalls & reported problems
Limacorporate SPA · SMR 3-Pegs -Glenoid LARGE · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 16, 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 08033390114004), received between Jan 29, 2026 and Jan 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity1
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Patient Device Interaction Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. PATIENT UNDERWENT PRIMARY SURGERY AT UNKNOWN DATE, PRIOR TO HOSPITAL DIGITAL RECORD SYSTEM IMPLEMENTATION, THEREFORE NO INFORMATION REGARDING ORIGINAL IMPLANT COULD BE RETRIEVED. ORIGINAL IMPLANT WAS REPORTED TO BE AND ASSEMBLY OF SMR HUMERAL COMPONENTS (TRAUMA HUMERAL BODY PN (B)(4), ECCENTRICAL ADAPTOR TAPER PN (B)(4), HUMERAL HEAD DIA50MM PN (B)(4) AND LARGE 3-PEGGED CEMENTED GLENOID (PN (B)(4)). DUE TO IMPLANT LOOSENING OVER TIME, OSTEOLYSIS CAUSED SIGNIFICANT AMOUNT OF GLENOID BONE LOSS. REPORTEDLY, PATIENT ENGAGED IN WEIGHTLIFTING, POSSIBLY CONTRIBUTING TO REPORTED LOOSENING. COMPONENTS WERE REMOVED AND DEMINERALIZED BONE MATRIX AND CANCELLOUS BONE CHIPS WERE USED TO GRAFT IN THE GLENOID. NEW HUMERAL BODY (PN (B)(4)) , ADAPTER (PN 1330.15.272), AND HUMERAL HEAD (PN (B)(4)) WERE IMPLANTED FOR A HEMI ARTHROPLASTY, UNTIL A SECOND PROCEDURE CAN BE UNDERGONE IN THE FUTURE TO IMPLANT A BASEPLATE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1959. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Joint Laxity; Osteolysis
MAUDE report 24210830 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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