BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER SHOULDER LINER

    MDR report key: 5532245 · Received March 29, 2016

    Report

    Report Number
    1822565-2016-00806
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Report Date
    March 1, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    KWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE PART AND LOT NUMBER IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PRODUCT HISTORY SEARCH CANNOT BE COMPLETED SINCE THE PART AND LOT NUMBER IS UNKNOWN. PATIENT¿S ACTIVITY LEVEL AND ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO A PIECE OF LINER BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186686 UNKNOWN ZIMMER SHOULDER LINER SHOULDER PROSTHESIS KWR ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention