BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM, 7MM

    MDR report key: 1081313 · Received July 24, 2008

    Report

    Report Number
    1220246-2008-00143
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED FOR EVAL, BUT HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A REVISION SURGERY AFTER FALLING AND SUBSEQUENTLY DISLOCATING HER SHOULDER. THE PT HAD AN ORIGINAL TOTAL SHOULDER REPLACEMENT SURGERY IN 2002. THE SURGEON'S COMMENT REGARDING THE OUTCOME OF THE REVISION SURGERY WAS THAT "IT WAS FINE". THE EXPLANTED DEVICE IS BEING RETURNED FOR EVAL. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL STEM, 7MM KWS ARTHREX, INC. NA 01.096

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other