SMR Shoulder 1379.59.110Recalls & reported problems
Limacorporate SPA · SMR Shoulder - TT HYBRID Glenoid Baseplate SMALL - PEG S · Class 2 · Implant
All models of SMR Shoulder (67)
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 08033390266703), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K163397); 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 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.
InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO ROTATOR CUFF FAILURE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL SHOULDER PROSTHESIS. DURING REVISION THE SURGEON REMOVED THE PRE-EXISTING TT HYBRID CEM. GLENOID SMALL (PN: 1379.59.110) AS WELL AS ALL OTHER COMPONENTS AND CONVERTED THE PROSTHESIS TO A REVERSE CONFIGURATION IMPLANTING THE FOLLOWING: FINNED STEM SHORT DIA17MM (PN: 1304.15.017), HUMERAL BODY REVERSE (PN: 1352.15.010), EXTENSION FOR HUMERAL REVERSE BODY (PN: 1352.15.001), REVERSE LINER STANDARD (PN: 1360.50.810), TT HYBRID REVERSE BASEPLATE SMALL (PN: 1379.15.160), GLENOSPHERE DIA 36MM (PN: 1374.09.111). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1962. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Muscle/Tendon Damage
MAUDE report 24950299 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K163397. One submission often covers many models, so check the product and lot details in each record.
- Z-1317-2023 · Feb 21, 2023 · Open, ClassifiedSMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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