BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 12.5X145

    MDR report key: 3696901 · Received March 25, 2014

    Report

    Report Number
    0001825034-2014-02077
    Event Type
    Injury
    Date Received
    March 25, 2014
    Report Date
    February 24, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED.¿ 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 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02187 AND 1825034-2014-02077 / -02078).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND RANGE OF MOTION, SORENESS, DYSFUNCTION, ELEVATED METAL ION LEVELS/METAL POISONING, AND METALLOSIS. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE RIGHT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173985 TAPERLOC POR LAT FMRL 12.5X145 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 483000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization