BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CCK FEMORAL

    MDR report key: 6927756 · Received October 7, 2017

    Report

    Report Number
    0001822565-2017-06900
    Event Type
    Injury
    Date Received
    October 7, 2017
    Report Date
    November 10, 2017
    Manufacturer
    .
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. X-RAY REVIEW INDICATES THAT THE FEMORAL COMPONENT EXHIBITS RADIOLUCENCY AT THE METAL-BONE AND CEMENT BONE INTERFACES CONSISTENT WITH LOOSENING. RADIOLUCENCY IS ALSO PRESENT IN THE TIBIAL COMPONENT SUGGESTING LOOSENING OF THE TIBIAL COMPONENT. THE FEMORAL COMPONENT APPEARS TO HAVE PROXIMALLY MIGRATED AND THERE IS MALPOSITION OF THE FEMORAL STEM. THERE IS POSSIBLE SUBSIDENCE OF THE TIBIAL TRAY. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS FURTHER REPORTED THE PATIENT'S RADIOGRAPH SHOWED A FEMORAL COMPONENT TO BE GROSSLY LOOSE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE. THE SURGEON NOTED THAT THE RIGHT FEMUR IS 5 CM SHORTER THAN THE LEFT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIOGRAPH SHOWED A FEMORAL COMPONENT TO BE GROSSLY LOOSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706550 UNKNOWN CCK FEMORAL PROSTHESIS, KNEE JWH . N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention