BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER SHOULDER

    MDR report key: 6096791 · Received November 11, 2016

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    Report

    Report Number
    0001822565-2016-04182
    Event Type
    Injury
    Date Received
    November 11, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. PRODUCT HISTORY SEARCH CANNOT BE COMPLETED SINCE THE LOT NUMBER IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS BEING CONSIDERED FOR A REVISION FOR AN UNKNOWN REASON FOLLOWING A SHOULDER ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746337 UNKNOWN ZIMMER SHOULDER SHOULDER PROSTHESIS HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other