SMR System 1374.15.305Recalls & reported problems
Limacorporate SPA · SMR System - Connector+Screw Small-R · Class 2 · Implant
All models of SMR System (47)
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 08033390271554), received between Apr 10, 2025 and Apr 10, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO THE PATIENT BEEN SORE AND STIFF AFTER THE PRIMARY SURGERY. THE PLAN WAS TO RELEASE MORE SOFT TISSUE, REPLACE THE GLENOSPHERE AND LINER AND ASSESS JOINT. THE FOLLOWING DEVICES WERE EXPLANTED AND REPLACED: · SMR AL2O3 - LINER MEDIUM Ø44 (PRODUCT CODE 1362.39.015, LOT #2404538 - STER. 2400063) - DEVICE NOT SOLD IN THE US. · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2410261 - STER. 2400086). · SMR REVERSE HP GLENOSPHERE 44 MM (PRODUCT CODE 1374.50.440, LOT #2409395 - STER. 2400076) - DEVICE NOT SOLD IN THE US. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2024. PATIENT IS A MALE, 43 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.
Patient problems: Implant Pain
MAUDE report 21812026 ↗
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 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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