SMR System 1304.15.190Recalls & reported problems
Limacorporate SPA · SMR System - Finned Stem Dia. 19 mm L. 80 mm · Class 2 · Implant
All models of SMR System (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390270823), received between Sep 24, 2025 and Apr 22, 2026 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity1
- Medical device site infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Patient Device Interaction Problem
REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO GLENOID BONE LOSS AND STEM LOOSENING. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. DURING ORIGINAL SURGERY FOLLOWING HUMERAL COMPONENTS WERE IMPLANTED: FINNED STEM DIA. 19 MM L. 80MM (PN: 1304.15.190, LOT: 2513645, STER. 2500096). 140° HUMERAL BODY REVERSE (PN: 1352.15.011, LOT: 2513035, STER. 2500105). EXTENSION FOR HUMERAL REVERSE BODY (PN: 1352.15.001, LOT: 2430343, STER. 2400276). SMR REVERSE LINER +3MM (PN: 1360.50.815, LOT: 21AT277, STER. 2200049). IN COMBINATION WITH GLENOID COMPONENTS FROM ANOTHER MANUFACTURER. DURING REVISION THE SURGEON EXPLANTED THE WHOLE ASSEMBLY, BOTH GLENOID AND HUMERAL COMPONENTS, THAT WERE REPLACED WITH GLENOID FROM OTHER MANUFACTURED AND SAME HUMERAL COMPONENTS WITH THE EXCEPTION OF A THICKER FINNED STEM AND A THICKER LINER, BELOW DETAILED: FINNED STEM DIA. 20 MM L. 80MM (PN: 1304.15.200). SMR REVERSE LINER +6MM (PN: 1360.50.820). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1961. EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Joint Laxity
MAUDE report 24950301 ↗InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPLAINT SOURCE REPORTED A REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOW GRAD INFECTION. THE HUMERAL STEM (PRODUCT CODE:1304.15.190 - LOT: 2400630 - STER. (B)(4) WAS EXPLANTED. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2024. PATIENT IS MALE, 85 YEARS OLD. THIS EVENT OCCURRED IN GERMANY.
Patient problems: Medical device site infection
MAUDE report 23130495 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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