BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MULTIPOLAR BIPOLAR CUP LINER

    MDR report key: 6059831 · Received October 27, 2016

    Report

    Report Number
    0002648920-2016-03239
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 30, 2016
    Report Date
    April 3, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    PMA / PMN Number
    PK833991
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. REVIEW OF DEVICE HISTORY RECORD FOR IDENTIFIED NO DEVIATIONS OR ANOMALIES.. THIS DEVICE WAS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER WAS UNABLE TO BE ASSEMBLED TO THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711311 ZIMMER MULTIPOLAR BIPOLAR CUP LINER HIP PROSTHESIS KWY ZIMMER MANUFACTURING B.V. 62854655

    Patients

    Seq Age Sex Outcome Treatment
    1