SMR Shoulder Glenosphere (REF 1374.09.105)Recalls & reported problems
Limacorporate SPA · Glenosphere - Small-R · 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 08033390002295), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K110598); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2018Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth
SMR REVERSE REVISION SURGERY PERFORMED ON (B)(6) 2018 DUE TO DISENGAGEMENT OF THE GLENOSPHERE FROM THE METAL BACK. ACCORDING TO THE INFO REPORTED, A CONVERSION TO REVERSE PROSTHESIS WAS ORIGINALLY PERFORMED ON (B)(6) 2018 BECAUSE OF LOOSENING OF THE CEMENTLESS STEM PREVIOUSLY IMPLANTED (PRIMARY SURGERY'S DATE UNKNOWN). THEN, 1 MONTH AFTER THE CONVERSION, LOOSENING OF THE CONNECTOR OF THE GLENOSPHERE OCCURRED. THIS CAUSED THE GLENOSPHERE TO COMPLETELY DISENGAGE FROM THE METAL BACK. ACCORDING TO SURGEON'S REMARKS, THE GLENOSPHERE HAS BEEN PROPERLY INSERTED WITH THE CONNECTOR SECURED FIRMLY DURING THE CONVERSION PERFORMED ON (B)(6) 2018. EVENT HAPPENED IN (B)(6).
Patient problems: Failure of Implant
MAUDE report 7832705 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.
- Z-1711-2016 · Apr 8, 2016 · TerminatedSMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
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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