BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR CUP LINER

    MDR report key: 6159919 · Received December 9, 2016

    Report

    Report Number
    0002648920-2016-04373
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 4, 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

    PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIPOLAR METAL SHELL 41 MM OD ITEM 00-5001-041-00 LOT # 63147307. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL AND PHOTOGRAPHIC INSPECTION REVEALED THE RING WAS DISASSEMBLED FROM THE LINER AND THERE WAS NOTED DAMAGE/DEFORMITY ON THE LOCKING FEATURE OF THE RING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON OPENING, THE RING CAME OFF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809698 MULTIPOLAR BIPOLAR CUP LINER PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 63123236

    Patients

    Seq Age Sex Outcome Treatment
    1