SMR SYSTEM
Report
- Report Number
- 3008021110-2026-00236
- Event Type
- Injury
- Date Received
- May 14, 2026
- Manufacturer
- LIMACORPORATE S.P.A
- Product Code
- HSD
- PMA / PMN Number
- K101263
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468230 | SMR SYSTEM | SMR SYSTEM - FINNED STEM DIA. 14 MM L. 80 MM | HSD | LIMACORPORATE S.P.A | 1304.15.140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |