SMR System 1304.15.140Recalls & reported problems
Limacorporate SPA · SMR System - Finned Stem Dia. 14 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
- 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 08033390270779), received between Aug 29, 2025 and Aug 29, 2025 — classified as 1 injury.
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 problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SHOULDER REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2025. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. ACCORDING TO THE INFORMATION RECEIVED, AT ROUTINE CLINICAL CHECK-UP, THERE WAS HYPEREMIC FISTULIZED SWELLING ON THE SCAR COMPATIBLE WITH ACUTE SEPTIC PHLEBITIS. THE PATIENT WAS HOSPITALIZED FOR EXPLANTATION, MULTIPLE SWABS, AND APPLICATION OF ANTIBIOTIC SPACER. THE DEVICES INVOLVED ARE THE FOLLOWING: SMR REVERSE HUMERAL BODY SHORT CODE 135215005 LOT 2320915 STER.(B)(4), SMR GLENOSPHERE Ø36MM SMALL-R CODE 137409105 LOT 2425777 STER. (B)(4), BONE SCREW Ø6,5 H.25MM CODE 842015020 LOT 2424500 STER. (B)(4), BONE SCREW Ø6,5 H.30MM CODE 842015030 LOT 2421627 STER. (B)(4), SMR REVERSE LINER STANDARD CODE 136050010 LOT 24AT3QP STER. (B)(4), SMR CEMENTLESS FINNED STEM CODE 130415140 LOT 2422600 STER. (B)(4), SMR UNCEMENT. GLENOID #SMALL-R CODE 137520005 LOT 2424337 STER. (B)(4). THE PATIENT IS 71 YEARS OLD. THIS EVENT OCCURRED IN ITALY.
Patient problems: Medical device site infection
MAUDE report 22920634 ↗
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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