BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN FINN EXTRACTOR

    MDR report key: 7005700 · Received November 7, 2017

    Report

    Report Number
    0001825034-2017-09957
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

    (B)(4). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE THE EXTRACTOR BECAME CROSS-THREADED AND COLD WELDED TO THE TAPER ADAPTOR AND THE SURGEON WAS UNABLE TO GET THE STEM OUT. THE SURGEON ENDED UP PUTTING NEW BUSHINGS ON THE OLD TAPER AND PUTTING THE OLD TAPER BACK IN. PATIENT WAS RE-IMPLANTED WITH SAME COMPONENT DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785218 UNKNOWN FINN EXTRACTOR HWI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR