SMR Shoulder Finned Stem (REF 1304.15.220)Recalls & reported problems
Limacorporate SPA · Finned humeral stems - 80mm (Ti6Al4V) dia.22mm · Class 2 · Implant
All models of SMR Shoulder (67)
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 08033390000963), received between May 11, 2026 and May 11, 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.
InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO INFECTION. DURING THE REVISION SURGERY SHOULDER REVERSE CONFIGURATION CONSISTING OF LIMA HUMERAL COMPONENTS AND DJO GLENOID COMPONENTS HAS BEEN CONVERTED INTO AN ANATOMIC CONFIGURATION COMPOSED BY DJO COMPONENTS ONLY. FOLLOWING PRE-EXISTING LIMA COMPONENTS HAVE BEEN EXPLANTED: SMR CEMENTLESS FINNED STEM (PN 1304.15.220, LOT. 2220341, STER. (B)(6); SMR HUMERAL EXTENSION + 9 MM (PN 1352.15.001, LOT. 2429616, STER. (B)(6); FINNED REVERSE HUM. BODY 140° (PN 1352.15.051, LOT. 2516852, STER. (B)(6); SMR REV. LINER RETENTIVE +6 MM (PN 1361.50.820, LOT. 24AT4LP, STER. (B)(6). SURGERY HAS BEEN COMPLETED AS INTENDED. PREVIOUS SURGERY OCCURRED ON (B)(6) 2026. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1956. EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Medical device site infection
MAUDE report 25134379 ↗
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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