SMR SHOULDER SYSTEM
Received May 11, 2026 · Event occurred Mar 13, 2026
Report 3008021110-2026-00203 · MDR key 25134379
Device
Generic name
Finned Humeral Stems - 80mm (ti6al4v) Dia.22mm
Manufacturer
Limacorporate S.p.a.Model number
1304.15.220Lot number
2220341
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Male
- Medical device site infection
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) AND THE STERILIZATION CHARTS FOR THE INVOLVED LOT NUMBERS WAS PERFORMED AND DID NOT REVEAL ANY PRE-EXISTING ANOMALY. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or 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.