BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP

    MDR report key: 6689110 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04535
    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
    PK042037
    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

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS - PART: 157452, NAME: M2A-MAGNUM MOD HD SZ 52 MM, LOT: 527620; PART: 192412, NAME: ECHO POR FMRL RED NC 12X140, LOT: 594570; PART: 139264, NAME: M2A-MAGNUM 52-60 MM 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, 0001825034-2017-04536, 0001825034-2017-04537.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470722 M2A MAGNUM PF CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 210200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R