BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3131141 · Received May 23, 2013

    Report

    Report Number
    1644408-2013-00285
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 11, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PT HAD ACUTE INFECTION OF THE WOUND. THE SURGEON REMOVED THE GLENOSPHERE AND LINER, WASHED OUT WITH SALINE ANTIBIOTICS, THEN REIMPLANTED THE GLENOSPHERE AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228853 RSP SHOULDER GLENOID HEAD W/RETAINING SCRE/NEUTRAL KWS ENCORE MEDICAL, L.P. 862C1232

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CAT# 508-00-032, LOT # 855C1194