BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A HI CARBON HEAD STANDARD NK

    MDR report key: 3971546 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06558
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    December 7, 2007
    Report Date
    November 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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 THIS TYPE OF EVENT CAN OCCUR: "MATERIEL SENSITIVITY REACTIONS." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "POSTOPERATIVE BONE FRACTURE AND PAIN." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06557 & 06558). ATTORNEY DID NOT RETURN DEVICE.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH 1825034-2014-06558 ASSOCIATED WITH PATIENT (B)(6) IS A DUPLICATE OF MEDWATCH 1825034-2013-06631 ASSOCIATED WITH PATIENT (B)(6). THIS MEDWATCH 1825034-2014-06558 IS CONSIDERED CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2007 DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD, ACETABULAR COMPONENTS AND TAPER LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448187 32MM M2A HI CARBON HEAD STANDARD NK PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 154020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R