BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER - HUMERAL STEM 11MM

    MDR report key: 1781281 · Received July 28, 2010

    Report

    Report Number
    2249697-2010-00923
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K955731
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHOULDER - OFF SET HUMERAL HEAD 50MMX21MM; CAT# 5352-5021; LOT # UNK WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. THE X-RAYS AND MEDICAL RECORDS WERE REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT PRESENTED WITH SHOULDER PAIN." THE EXACT IMPLANTATION DATE WAS NOT PROVIDED, HOWEVER, IT WAS INDICATED THAT THE REPORTED DEVICES WERE IMPLANTED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOULDER - HUMERAL STEM 11MM IMPLANT KWS STRYKER ORTHOPAEDICS MAHWAH NA 19541101

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention