BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2093594 · Received April 14, 2011

    Report

    Report Number
    1644408-2011-00199
    Event Type
    Other
    Date Received
    April 14, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE CEMENT WAS DRYING WHEN THE STEM TURNED RESULTING IN DISLOCATION. THERE WAS A FRACTURE IN THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW KWS ENCORE MEDICAL, L.P. 862C1042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 508-00-032, LOT 855C1017| 506-03-134, LOT 54005265| 506-03-130, LOT 835C1000| 832C1013| 506-03-118, LOT 832C1021 &| 508-00-000, LOT 848C1083| 508-32-104, LOT 866C1068