BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM TRISPIKE CUP 56ODX50ID

    MDR report key: 3885018 · Received June 19, 2014

    Report

    Report Number
    0001825034-2014-05656
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    January 28, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 1. MATERIAL SENSITIVITY REACTIONS. 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. 15. 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 PATIENT (REFERENCE 1825034-2014-02422 AND 05656).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN; SWELLING; INFLAMMATION; DIFFICULTY STANDING, SITTING, AND WALKING; AND MOVING UP AND DOWN STAIRS. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATE THAT LEFT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2014 WAS DUE TO PAIN, METALLOSIS, SWELLING AND EVIDENCE OF FLUID COLLECTION. THE PATIENT¿S OPERATIVE REPORT NOTED GREENISH GRAY FLUID. THE ACETABULAR CUP WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2013 PATIENT¿S BLOOD WAS TESTED. 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
    362028 MAGNUM TRISPIKE CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 788370

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R