BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP FMRL 6.0MM

    MDR report key: 3950149 · Received July 22, 2014

    Report

    Report Number
    0001825034-2014-06338
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBL
    PMA / PMN Number
    PK050441
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." AND "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS. " THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05842 /-06337 /-06338).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013, DUE TO PAIN. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF METALLOSIS, A LOOSE ACETABULAR CUP, PINK GRAY CHEESY CONSISTENCY DEBRIS, BONY CHANGES AND DISCOLORATION OF THE ACETABULUM, OSTEOPHYTES, STEM WAS RETROVERTED, AND A FRACTURE OF THE GRATER TROCHANTER. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428455 TAPERLOC MICROP FMRL 6.0MM PROSTHESIS, HIP MBL BIOMET ORTHOPEDICS N/A 972310

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R