SMR SYSTEM
Received May 14, 2026
Report 3008021110-2026-00236 · MDR key 25168980
Device
Generic name
Smr System - Finned Stem Dia. 14 Mm L. 80 Mm
Manufacturer
Limacorporate S.p.aModel number
1304.15.140Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Medical device site infection
Narrative
Description of Event or Problem
ON (B)(6) 2026, A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL SMR REVERSE SYSTEM COMPONENTS WERE REMOVED AND A SPACER FROM A THIRD-PARTY COMPANY WAS IMPLANTED. THE PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6) 2025. PRODUCTS INVOLVED: SMR REVERSE FINNED HUMER. BODY (PRODUCT CODE 1352.15.050, LOT N. 2511799, STER. N. 2500099). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT N. 25AT11U, STER. N. 2500098). SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT N. 2512490, STER. N. 2500105). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT N. 2529993, STER. N. 2500199). SMR UNCEMENT. GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT N. 2518393, STER. N. 2500158). CORTIC.BONE SCREW D.4,5 L.22MM (PRODUCT CODE 8431.15.022, LOT N. 2219846, STER. N. 2200263). CORTIC.BONE SCREW D.5 L.30 MM (PRODUCT CODE 8432.15.030, LOT N. 2329548, STER. N. 2300281). SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT N. 2109121, STER. N. 2100209). PATIENT: FEMALE, 74 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.
Additional Manufacturer Narrative
INVESTIGATION: REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL INVOLVED LOTS AND STERILIZATION BATCHES REVEALED NO ANOMALIES. THIS IS THE FIRST COMPLAINT RECEIVED FOR ALL THE LOTS LISTED ABOVE. A FINAL MDR WILL BE SHARED UPON COMPLETION OF THE INVESTIGATION.