BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INSR +3

    MDR report key: 3895964 · Received June 26, 2014

    Report

    Report Number
    0001825034-2014-05746
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 4, 2014
    Report Date
    August 15, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 1825034-2014-00184.

    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. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05744/05747).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO AN UNKNOWN REASON. DURING THE PROCEDURE, THE TAPER ADAPTER AND FEMORAL STEM WERE DIFFICULT TO SEPARATE. SUBSEQUENTLY, ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS. THERE WAS A DELAY OF 2 HOURS IN THE PROCEDURE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373741 M2A-MAGNUM 52-60MM TPR INSR +3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 311530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R