BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXGEN CRUCIATE RETAINING (CR) ARTICULAR SURFACE SIZE GREEN / C-H 10MM HEIGHT

    MDR report key: 6230443 · Received January 6, 2017

    Report

    Report Number
    0001822565-2017-00075
    Event Type
    Death
    Date Received
    January 6, 2017
    Report Date
    September 8, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS - MIS TIBIA SIZE 5 CATALOG# 00-5950-047-10, NEXGEN FEMUR CATALOG# 00-5950-014-06. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. BASED ON THE INFORMATION PROVIDED PATIENT EXPIRED (B)(6) 2016. 2016. IT WAS INDICATED THAT THE PATIENT COULD POSSIBLY UNDERGO A POLY SWAP PROCEDURE ON (B)(6), AND INFORMATION WAS RECEIVED ON DECEMBER 21ST THAT THE REVISION PROCEDURE WOULD NOT OCCUR DUE TO PATIENT DEATH. WITH THE CURRENT INFORMATION PROVIDED IT IS UNKNOWN WHAT THE CAUSE OF DEATH IS AND IF THERE IS ANY RELATION TO THE IMPLANTED PRODUCTS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (DHR) 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 CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS BEING EVALUATED FOR A REVISION, HOWEVER PATIENT EXPIRED PRIOR TO THE REVISION BEING PERFORMED. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE CAUSE OF DEATH OR IF THE INITIAL IMPLANTS CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11577 NEXGEN CRUCIATE RETAINING (CR) ARTICULAR SURFACE SIZE GREEN / C-H 10MM HEIGHT PROSTHESIS, KNEE JWH ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death