BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 1981262 · Received February 2, 2011

    Report

    Report Number
    1644408-2011-00059
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAS HAD 2 PREVIOUS REVISIONS, NO SUPER-SPIRANTS ALONG WITH INFECTION. THE SURGEON DECIDED TO REMOVE THE GLENOSPHERE HUMERAL SHELL, INSERT AND FOUR LOCKING SCREWS. THERE WAS NOTHING REPLACED/REVISED THE THIRD TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW KWS ENCORE MEDICAL, L.P. 54003071

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)| (B)(4), LOT 53993243