SMR Shoulder 1379.59.330Recalls & reported problems
Limacorporate SPA · SMR Shoulder - TT HYBRID Glenoid Baseplate LARGE - PEG L · 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 08033390267670), received between Jan 26, 2026 and Jan 26, 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
- Implant Pain1
- Loss of Range of Motion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. PATIENT COMPLAINED OF PAIN, DISCOMFORT AND REDUCED SHOULDER FUNCTION. PREVIOUS SURGERY "IS UNKNOWN", AS WELL AS COMPLETE INFORMATION OF ORIGINAL PROSTHETIC ASSEMBLY. DURING REVISION THE COMPLETE ASSEMBLY CONSISTING OF SMR HUMERAL HEAD Ø48 MM (PART NUMBER 1322.09.480), SMR FINNED HUMERAL BODY (PART NUMBER 1350.15.110), SMR FINNED STEM SHORT D.16 (PART NUMBER 1304.15.016) AND TT HYBRID CEM. GLENOID LARGE (PART NUMBER 1379.59.330) HAS BEEN REMOVED, HOWEVER NO INFORMATION REGARDING NEWLY IMPLANTED COMPONENTS HAS BEEN PROVIDED. NONETHELESS SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1961. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Implant Pain; Loss of Range of Motion
MAUDE report 24178585 ↗
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 Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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