BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP BASEPLATE, 30MM, W/P2 COATING

    MDR report key: 18874138 · Received March 11, 2024

    Report

    Report Number
    1644408-2024-00278
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 9, 2024
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    KWS
    UDI-DI
    00888912144391
    PMA / PMN Number
    K112069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO PREVIOUS REPORT NUMBER 1644408-2023-001842; 508-32-204, S808 - INFECTION, REVISION SURGERY IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969865 RSP BASEPLATE, 30MM, W/P2 COATING PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ENCORE MEDICAL L.P UNKNOWN 00888912144391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other