BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2011721 · Received March 1, 2011

    Report

    Report Number
    1644408-2011-00113
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 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 - REMOVED ALL PRODUCTS DUE TO AN INFECTION IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HA-COAT RSP BASEPLATE KWS ENCORE MEDICAL, L.P. A1000002

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 503-03-126, LOT 54040562| 503-03-126, LOT 54033058| 503-03-126, LOT A1000001 REST ON| (B)(4), LOT 54050148| (B)(4), LOT A1000000| (B)(4), LOT A1000001| 503-03-126