BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2093712 · Received April 21, 2011

    Report

    Report Number
    1644408-2011-00226
    Event Type
    Other
    Date Received
    April 21, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT FELL ONTO SHOULDER THAT HAD AN RSP. THE DOCTOR REVISED THE LOOSE STEM WITH A LONGER STEM 175MM (SIZE 8).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER STANDARD HUMERAL INSERT SOCKET KWS ENCORE MEDICAL, L.P. 50800008

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 508-32-103, LOT NA| 508-00-000, LOT NA