BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IB2 BEARING

    MDR report key: 7080540 · Received December 4, 2017

    Report

    Report Number
    0001822565-2017-08294
    Event Type
    Death
    Date Received
    December 4, 2017
    Report Date
    July 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). INITIAL SURGERY WAS PERFORMED IN 1995. CONCOMITANT MEDICAL PRODUCTS - UNKNOWN IB2 FEMUR. UNKNOWN IB2 TIBIAL TRAY. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPIRED AFTER SHE SLIPPED IN THE BATHROOM, BROKE HER NOSE AND HEMORRHAGED THEREFORE THIS IS NOT DEVICE OR PROCEDURE RELATED AND NO FURTHER INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS BEING SCHEDULED FOR A LEFT KNEE REVISION PROCEDURE DUE TO UNKNOWN REASONS. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS BEING SCHEDULED FOR A LEFT KNEE REVISION PROCEDURE DUE TO INSTABILITY AND PAIN. IT WAS FURTHER REPORTED THE PATIENT HAS WORN THROUGH THE POLYETHYLENE ARTICULAR SURFACE AFTER APPROXIMATELY TWENTY-TWO YEARS. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860951 UNKNOWN IB2 BEARING PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention