BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO BI-METRIC

    MDR report key: 6689112 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04536
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 6, 2016
    Report Date
    October 11, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS: PART: 157452 NAME: M2A-MAGNUM MOD HD SZ 52MM LOT: 527620; PART: US157858 NAME:M2A-MAGNUM PF CUP 58ODX52ID LOT: 210200; PART: 139264 NAME: M2A-MAGNUM 52-60MM TPR INSRT-6 LOT: 404580. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-04533, 0001825034-2017-04535, 0001825034-2017-04537.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATINET UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS POST INITIAL IMPLANTATION DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND NO FIRTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470725 ECHO BI-METRIC PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 594570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R