BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT

    MDR report key: 6682664 · Received June 30, 2017

    Report

    Report Number
    0001825034-2017-04365
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    November 30, 2015
    Report Date
    July 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT WAS DETERMINED TO NOT BE REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: PART:11-163669 NAME:32MM M2A MOD HEAD STD NK LOT:722710. PART:15-103682 NAME: M2A-T UNIV 2-HOLE SHL SZ 41/52 LOT:286590. PART:15-105004 NAME:M2A-TAPER LINER SZ 41/32 LOT:305800. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. INITIAL INVOICE SHOWS 2 FEMORAL HEADS. IT IS UNCERTAIN IF THIS DEVICE WAS ORIGINALLY IMPLANTED. FURTHER FOLLOW UP ATTEMPTS ARE ONGOING. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04366, 0001825034-2017-04367, 0001825034-2017-04368.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 12 YEARS POST INITIAL IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462826 M2A MODULAR HEAD COMPONENT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 922350

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R