BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM +6

    MDR report key: 3102771 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01306
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 10, 2013
    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
    PATIENT

    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: "MATERIAL SENSITIVITY REACTIONS." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01305 / 01307). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 AND ALLEGES ELEVATED COBALT CHROMIUM LEVELS AND METALLOSIS. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATE. THERE HAS BEEN NO REPORTED REVISION PROCEDURE AND NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203482 SELEX/MAGNUM MODULAR HEAD 40MM +6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 646150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R