BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET OFFSET ADAPTER

    MDR report key: 6946309 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08342
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 18, 2017
    Report Date
    January 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION WILL BE SENT TO THE COMPLAINANT. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCT: VANGUARD SSK FEMORAL SCREW, CAT#: 183315 LOT#: 935520. VANGUARD SSK FEMORAL, CAT#: 185270 LOT#: 2534842. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT HAS BEEN DISCARDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08341, 0001825034-2017-08343.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL SCREW HAD FALLEN OUT OF THE FEMUR WHEN IMPACTING. THE SURGICAL TEAM THEN ATTEMPTED TO THREAD THE SCREW INTO THE OFFSET ADAPTER, WHICH WAS UNSUCCESSFUL. A SECOND SCREW WAS OPENED AND AGAIN ATTEMPTED WITH THE SAME RESULTS. FINALLY THE SURGEON ASSEMBLED THE FEMUR AND ADAPTER WITH IMPACTION TECHNIQUE ONLY, NO SCREW WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL SCREW HAD FALLEN OUT OF THE FEMUR WHEN IMPACTING. THE SURGICAL TEAM THEN ATTEMPTED TO THREAD THE SCREW INTO THE OFFSET ADAPTER, WHICH WAS UNSUCCESSFUL. A SECOND SCREW WAS OPENED AND AGAIN ATTEMPTED WITH THE SAME RESULTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725652 BIOMET OFFSET ADAPTER PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 550220

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR