SMR System 1304.15.150Recalls & reported problems
Limacorporate SPA · SMR System - Finned Stem Dia. 15 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 08033390270786), received between Feb 25, 2026 and Feb 25, 2026 — 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.
InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
INITIAL REPORT (B)(4). REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO INFECTION. THE IMPLANTED DEVICES WERE REMOVED AND SPACER INSERTED WHILE INFECTION RESOLVES. PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. THE FOLLOWING DEVICES WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.150, LOT: 2119081 - STER: (B)(6)) - SOLD IN US. SMR REVERSE HUMERAL BODY (PRODUCT CODE: 1352.20.010, LOT:2124103 - STER: (B)(6)) - NOT SOLD IN US SMR REVERSE HP LINER LONG (PRODUCT CODE: 1362.09.020, LOT: 2116715 - STER: (B)(6)) - SOLD IN US SMR CONNECTOR SMALL R (PRODUCT CODE: 1374.15.305, LOT: 2201510 - STER: 2200042) - SOLD IN US SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE: 1374.50.440, LOT: 2122191 - STER: (B)(6)) - SOLD IN US SMR UNCEMENT. GLENOID #SMALL-R (PRODUCT CODE: 1375.20.005, LOT: 2124096 - STER: (B)(6)) - NOT SOLD IN US BONE SCREW Ø6,5 H.25MM (PRODUCT CODE: 8420.15.020, LOT: 2024416 - STER: (B)(6)) - SOLD IN US BONE SCREW Ø6,5 H.30MM (PRODUCT CODE: 8420.15.030, LOT:2106481 - STER: (B)(6)) - SOLD IN US PATIENT IS A FEMALE, 60 YEARS OLD. EVENT OCCURRED IN CANADA.
Patient problems: Medical device site infection
MAUDE report 24444030 ↗
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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