BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2170143 · Received June 29, 2011

    Report

    Report Number
    1644408-2011-00370
    Event Type
    Other
    Date Received
    June 29, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 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 DEVELOPED PROXIMAL HUMERAL BONE LOSS CAUSING CEMENT MANTLE TO LOOSEN. THE SURGEON DETERMINED THIS WAS A DEGENERATIVE ISSUE AND NOT AN IMPLANT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HA-COATED GLENOID BASEPLATE KWS ENCORE MEDICAL, L.P. 53955916

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 506-00-006, LOT 53979779| 506-03-118, LOT 53970734| 506-03-130, LOT 53982208| 508-36-101, LOT 5395589| 508-03-134, LOT 53907635| 506-03-122, LOT 53980347