BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX54MM

    MDR report key: 3884659 · Received June 19, 2014

    Report

    Report Number
    0001825034-2014-05591
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 3, 2013
    Report Date
    June 6, 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
    FL, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "MATERIAL SENSITIVITY REACTIONS. " 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 1825034-2014-01571/-05591).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. THE MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2013 LEFT HIP REVISION OPERATIVE REPORT NOTED THE REVISION WAS DUE PAIN AND THE PRESENCE OF A HIP EFFUSION, DEBRIS, SYNOVIAL FLUID AND TISSUE, CORROSION, A MEDIAL DEFECT, METALLOSIS AND OSTEOLYSIS. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360522 M2A 1 PC SHELL 38MMX54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 866120

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R