BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21974540 · Received May 7, 2025

    Report

    Report Number
    3005180920-2025-00392
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    March 26, 2024
    Report Date
    May 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040715928
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT ARE NOT AVAILABLE AT THE MOMENT AND IT IS NOT POSSIBLE TO PERFORM BATCH REVIEW. ADDITIONAL IMPLANTS INVOLVED. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452). REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452). REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE - Ø27X25 (K170452). REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE - Ø39X27 (K170452). REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452). REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452). INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING INFORMATION ON THE LOTS OF THE DEVICES INVOLVED IN THIS EVENT IT WAS NOTICED THAT THE EVENT HAD ALREADY BEEN REPORTED IN A PREVIOUS COMPLAINT. THEREFORE, THE PRESENT REPORT, MDR 2025-00392, IS A DUPLICATE OF REPORT MDR 2025-00100 SUBMITTED ON 11 FEBRUARY 2025.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT HAS UNDERGONE REVISION DUE TO INFECTION. THE SURGEON REVISED ALL COMPONENTS SUCCESSFULLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485281 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 KWS MEDACTA INTERNATIONAL SA 04.01.0184 07630040715928

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention