BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NEXGEN FEMORAL COMPONENT

    MDR report key: 7778938 · Received August 13, 2018

    Report

    Report Number
    0001822565-2018-03889
    Event Type
    Death
    Date Received
    August 13, 2018
    Date of Event
    October 9, 2017
    Report Date
    September 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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

    (B)(4). SEAN M. KEARNS, MD, BRIAN M. CULP, MD, DANIEL D. BOHL, MD, MPH, SCOTT M. SPORER, MD, CRAIG J. DELLA VALLE, MD, BRETT R. LEVINE, MD, MS "ROTATING HINGE IMPLANTS FOR COMPLEX PRIMARY AND REVISION TOTAL KNEE ARTHROPLASTY" THE JOURNAL OF ARTHROPLASTY 33 (2018) 766-770. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. 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 CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-03885, 0001822565-2018-03892. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE THAT THIRTEEN PATIENTS DIED PRIOR TO THE TWO-YEAR FOLLOW-UP. THE CAUSE OF DEATHS ARE NOT LISTED HOWEVER; THERE WERE NO KNOWN IMPLANT-RELATED COMPLICATIONS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620686 UNKNOWN NEXGEN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death