BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP LAT FMRL 5.0MM

    MDR report key: 3690736 · Received March 20, 2014

    Report

    Report Number
    0001825034-2014-01899
    Event Type
    Injury
    Date Received
    March 20, 2014
    Report Date
    July 27, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062994
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 7 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01893 / 01899).

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2009. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. THERE IS NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. 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
    167258 TAPERLOC MICROP LAT FMRL 5.0MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 949790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention