BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 4251122 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08567
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 20, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08567 / 08568).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THAT THIS REPORT IS A DUPLICATE OF MEDWATCH 1825034-2014-08473 ASSOCIATED WITH PATIENT (B)(4). THIS MEDWATCH 1825034-2014- 08567 IS CONSIDERED CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2007. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6), 2014 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737358 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 410930

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R