BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    180MM 2/3 RING

    MDR report key: 6961080 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-09148
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KTT
    PMA / PMN Number
    PK953406
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REVIEWED BOTH DHF¿S AND THE CORRECT LABEL IS ATTACHED TO THE LABEL PAGE. PULLED PRODUCT LABELED 32-482524 LOT M981270 AND CONFIRMED THAT ALL FIVE PARTS ARE ACTUALLY 13040 LOT M955090. IT WAS VERIFIED NON OF THE MISLABELED PRODUCT WAS IN THE FIELD. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 WAS REPORTED THAT THE INCORRECT TRIAL WAS RECEIVED. A RING WAS PACKAGED IN THE CONTAINER FOR A VANGUARD TRIAL BEARING. THIS WAS FOUND AT A DISTRIBUTOR'S OFFICE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740161 180MM 2/3 RING APPLIANCE, FIXATION KTT ZIMMER BIOMET, INC. N/A 955090

    Patients

    Seq Age Sex Outcome Treatment
    1