BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHOULDER IMPLANT

    MDR report key: 2553192 · Received April 25, 2012

    Report

    Report Number
    2249697-2012-00501
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    February 17, 2012
    Report Date
    April 8, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSD
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "I SPOKE WITH A FRIEND YESTERDAY WHO WENT THROUGH FULL RIGHT SHOULDER REPLACEMENT SURGERY USING A STRYKER IMPLANT. THE SHOULDER IS NOW REGULARLY SLIPPING OUT OF SOCKET AND THE ARM MUST BE IN A SLING. FURTHER DETAILS OF THE SURGERY ARE UNK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SHOULDER IMPLANT IMPLANT HSD STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other