BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 24210830 · Received January 29, 2026

    Report

    Report Number
    3008021110-2026-00090
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    April 15, 2025
    Report Date
    January 29, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWS
    UDI-DI
    08033390114004
    PMA / PMN Number
    K153722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANTED COMPONENTS HAVE BEEN DISCARDED THEREFORE CANNOT BE RETURNED TO MANUFACTURER FOR IDENTIFICATION AND ANALYSIS. NO REVIEW OF MANUFACTURING RECORDS FOR COMPLAINED PARTS CAN BE PERFORMED EITHER SINCE LOT NUMBER IS UNKNOWN. NO X-RAYS NOR PICTURES OF EXPLANTED COMPONENTS WERE PROVIDED EITHER. FROM FOLLOW-UP COMMUNICATION WITH COMPLAINT SOURCE IT WAS CONFIRMED THAT NO FURTHER INFORMATION REGARDING THE CASE CAN BE RETRIEVED, THEREFORE NO FURTHER ROOT CAUSE INVESTIGATION IS POSSIBLE. TAKING INTO ACCOUNT THE INVOLVED PRODUCT FAMILY SMR SHOULDER, NO ADVERSE TREND HAS BEEN IDENTIFIED FOR REPORTED ISSUE IN THE LAST YEAR. ACCORDING TO INVESTIGATION CARRIED OUT, NO CORRECTIVE ACTION IS NEEDED FOR THIS EVENT. IF ANY ADDITIONAL INFORMATION IS RECEIVED THAT WOULD CHANGE OR ALTER ANY CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET IN ORDER TO DETECT ANY SIMILAR EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. PATIENT UNDERWENT PRIMARY SURGERY AT UNKNOWN DATE, PRIOR TO HOSPITAL DIGITAL RECORD SYSTEM IMPLEMENTATION, THEREFORE NO INFORMATION REGARDING ORIGINAL IMPLANT COULD BE RETRIEVED. ORIGINAL IMPLANT WAS REPORTED TO BE AND ASSEMBLY OF SMR HUMERAL COMPONENTS (TRAUMA HUMERAL BODY PN (B)(4), ECCENTRICAL ADAPTOR TAPER PN (B)(4), HUMERAL HEAD DIA50MM PN (B)(4) AND LARGE 3-PEGGED CEMENTED GLENOID (PN (B)(4)). DUE TO IMPLANT LOOSENING OVER TIME, OSTEOLYSIS CAUSED SIGNIFICANT AMOUNT OF GLENOID BONE LOSS. REPORTEDLY, PATIENT ENGAGED IN WEIGHTLIFTING, POSSIBLY CONTRIBUTING TO REPORTED LOOSENING. COMPONENTS WERE REMOVED AND DEMINERALIZED BONE MATRIX AND CANCELLOUS BONE CHIPS WERE USED TO GRAFT IN THE GLENOID. NEW HUMERAL BODY (PN (B)(4)) , ADAPTER (PN 1330.15.272), AND HUMERAL HEAD (PN (B)(4)) WERE IMPLANTED FOR A HEMI ARTHROPLASTY, UNTIL A SECOND PROCEDURE CAN BE UNDERGONE IN THE FUTURE TO IMPLANT A BASEPLATE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1959. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269012 SMR SHOULDER SMR 3-PEGS GLENOID - LARGE KWS LIMACORPORATE S.P.A 1379.50.030 08033390114004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention