BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2093572 · Received April 14, 2011

    Report

    Report Number
    1644408-2011-00201
    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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAS HAD MULTIPLE SURGERIES IN THE LAST SIX WEEKS. SHE DISLOCATED AFTER HER LAST REVISION. IT WAS DETERMINED THE BEST OPTION WAS TO CONVERT TO A HEMI. ALL IMPLANTS WERE REMOVED EXCEPT HER WELL FIXED STEM. AN RSP ADAPTER AND FOUNDATION HEAD WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/ RETAINING SCREW KWS ENCORE MEDICAL, L.P. 864C1028

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 508-32-104, LOT 866C1077| 506-03-138, LOT 837C1002| 506-03-138, LOT 836C1003| 508-01-032, LOT 859C1003| 508-00-000, LOT 854C1002| 506-03-138, LOT 837C1001