BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER STEM

    MDR report key: 5996606 · Received October 4, 2016

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    Report

    Report Number
    0001822565-2016-03500
    Event Type
    Injury
    Date Received
    October 4, 2016
    Report Date
    September 8, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/22056324. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED ONE PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648118 UNKNOWN ZIMMER STEM SHOULDER PROSTHESIS HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R