BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX56MM CUP

    MDR report key: 4100314 · Received September 18, 2014

    Report

    Report Number
    0001825034-2014-07801
    Event Type
    Injury
    Date Received
    September 18, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05045, -07722, -07799, & -07801).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 ALLEGEDLY DUE TO METALLOSIS AND ELEVATED METAL ION LEVELS. REVIEW OF INVOICE HISTORY INDICATES THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2000, WHICH WAS REVISED (B)(6) 2014 AND AN INITIAL TOTAL HIP ARTHROPLASTY ON THE OPPOSITE HIP ON (B)(6) 2002. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE 2002 ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580513 M2A 38MMX56MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 185590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization