BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -6MM

    MDR report key: 7448385 · Received April 20, 2018

    Report

    Report Number
    0001825034-2018-02859
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    February 7, 2016
    Report Date
    April 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034 - 2018 - 02857 ; 0001825034 - 2018 - 02858 . MEDICAL DEVICES: 11-301300 ARCOS CON SZ A STD 50MM LOT 712270; 11-300818 ARCOS 18X150MM SPL TPR DIST LOT 140030 . REPORTED EVENT WAS CONFIRMED WITH REVIEW OF MEDICAL RECORDS RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS WOUND DEHISCENCE WITH UNCONTROLLED BLEEDING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289437 36MM COCR MOD HD -6MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 279730

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R