BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 24442723 · Received February 25, 2026

    Report

    Report Number
    3008021110-2026-00124
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 25, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390273619
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANTED COMPONENT WAS DISCARDED THEREFORE NOT AVAILABLE FOR TESTING. REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT HIGHLIGHT ANY PRE-EXISTING NON CONFORMITY ON THE INVOLVED LOT RELEVANT TO THE ISSUE. FROM FOLLOW UP COMMUNICATION WITH SALES REPRESENTATIVE IT WAS LEARNED THAT LOOSE LINER WAS DETECTED DURING REVISION SURGERY BUT NO INDICATION OF COMPONENT DAMAGE WAS REPORTED BY SURGEON. NO PICTURES OF EXPLANTED COMPONENT WAS SHARED TO CONFIRM ITS CONDITION AND X-RAYS WERE NOT MADE AVAILABLE. NO ISSUES DURING ORIGINAL SURGERY WERE REPORTED EITHER. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISASSEMBLY OF COMPONENTS. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND FOLLOWING COMPONENTS WERE IMPLANTED: SMR REVERSE LINER + 6 MM (PART NUMBER: 1360.50.820, LOT. 24AT5P8, STERILIZATION N. 2500009). SMR CONNECTOR SMALL STD (PART NUMBER: 1374.15.310, LOT: 2500907, STERILIZATION N. 2500027). SMR GLENOSPHERE Ø 36MM (PART NUMBER: 1374.09.111, LOT: 2506966, STERILIZATION N. 2500066). SMR METAL-BACK GLENOID SMALL (PART NUMBER: 1375.21.020, LOT: 2435106, STERILIZATION N. 2500053). SMR CEMENTLESS FINNED STEM (PART NUMBER: 1304.15.210, LOT: 2102161, STERILIZATION N. 2100078). SOME MONTHS AFTER ORIGINAL SURGERY THE ABOVE-MENTIONED REVERSE POLY LINER WAS FOUND LOOSE. DURING REVISION SURGERY LINER WAS EXPLANTED AND REPLACED WITH A NEW ONE FROM SAME LOT. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1940. THE EVENT OCCURRED IN UNITES STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371997 SMR SHOULDER REVERSE LINERS 36MM (UHMWPE) +6MM PHX LIMACORPORATE S.P.A. 1360.50.820 24AT5P8 08033390273619

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention