SMR System 1322.09.541Recalls & reported problems
Limacorporate SPA · SMR System - Humeral Head Dia. 54 mm H. 18 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 08033390274432), received between Jan 9, 2026 and Jan 9, 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
- Muscle/Tendon Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO CUFF FAILURE. PREVIOUS SURGERY DATE IS UNKNOWN, AS WELL AS COMPLETE ASSEMBLY INFORMATION OF PREVIOUS IMPLANT. TOTAL SHOULDER ARTHROPLASTY WAS CONVERTED TO A REVERSE SHOULDER ARTHROPLASTY STABILITY DUE TO POST-OPERATIVE ROTATOR CUFF TEAR. DURING REVISION THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD D.54 H.18MM (PART NUMBER 1322.09.541, LOT UNKNOWN), SMR FINNED HUMERAL BODY (PART NUMBER 1350.15.110), LINER F.MET.BACK GLEN.STANDARD (PART NUMBER 1377.50.010). AND REPLACED WITH REVERSE CONFIGURATION COMPONENTS: CONNECTOR AND SCREW SMALL STD (PART NUMBER 1374.15.310), GLENOSPHERE ECC DIA 36MM (PART NUMBER 1376.09.031), HUMERAL BODY REVERSE SHORT (PART NUMBER 1352.15.005), RETENTIVE LINER REVERSE STD DIA 36MM (PART NUMBER 1360.54.811). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1939. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Muscle/Tendon Damage
MAUDE report 24018206 ↗
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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