BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBALT CHROME FEMORAL HEAD

    MDR report key: 6834229 · Received August 31, 2017

    Report

    Report Number
    3006946279-2017-00148
    Event Type
    Death
    Date Received
    August 31, 2017
    Date of Event
    July 31, 2017
    Report Date
    August 31, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K911684. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06522, 0009610576-2017-00032,

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT HIP REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO INFECTION. THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE, WITHIN FOUR DAYS OF THE REVISION PROCEDURE. IT WAS REPORTED THE PATIENT HAD SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614328 COBALT CHROME FEMORAL HEAD PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L. N/A 00J3434097

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R ARCOM RINGLOC LINER PN11-105924 LN3449798| EXCEPTION FEMORAL STEM PNPS126Y06 LN0000950000| RINGLOC RIMCUP SHELL PN1045-56 LN2014100605