BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 1943855 · Received December 22, 2010

    Report

    Report Number
    1644408-2010-00692
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS EXPERIENCING PAIN, AND HAD AN INFECTION. ALL IMPLANTS WERE STABLE. THE SURGEON CHANGED THEM TO BE SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL KWS ENCORE MEDICAL, L.P. 54015559

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention