BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 60ODX54ID

    MDR report key: 4093620 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07732
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    April 11, 2014
    Report Date
    August 21, 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
    OH, 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 RELATED TO THE EVENT. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-07728 /-07729 /-07730 /-07731 /-07732).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013 AND RECEIVED A TAPERLOC HIP. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND REPLACED WITH A SPACER MOLDA. ON (B)(6) 2014, THE SPACER MOLDS WERE REMOVED AND REPLACED WITH AN ECHO BI-METRIC STEM AND A MAGNUM TRI-SPIKE CUP. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION. THIS DISLOCATION WAS A RESULT OF THE VERSION (ROTATION) OF THE ECHO STEM. THE STEM, MODULAR HEAD, AND ACTIVE ARTICULATION POLY WERE REMOVED AND REPLACED WITH AN ARCOS STEM AND HEAD. REVIEW OF INVOICE HISTORY VERIFIED THE IMPLANT AND REVISION SURGERY DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573762 M2A-MAGNUM PF CUP 60ODX54ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 730600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R