BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM TRISPIKE CUP 52ODX46ID

    MDR report key: 3182036 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02132
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 27, 2012
    Report Date
    April 29, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062995
    Removal / Correction Number
    N/A
    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, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND UNDER WARNINGS, NUMBER 4 STATES, "TIGHT FIXATION OF ALL NON-CEMENTED COMPONENTS AT THE TIME OF SURGERY IS CRITICAL TO THE SUCCESS OF THE PROCEDURE. EACH COMPONENT MUST PROPERLY PRESS FIT INTO THE HOST BONE WHICH NECESSITATES PRECISE OPERATIVE TECHNIQUE AND THE USE OF SPECIFIED INSTRUMENTS. BONE STOCK OF ADEQUATE QUALITY MUST BE PRESENT AND APPRAISED AT THE TIME OF SURGERY." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01007, 01007-1 AND 02132). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010 . SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012. MEDICAL RECORDS PROVIDED INDICATE REVISION WAS DUE TO GROIN PAIN, ILIOPSOAS TENDONITIS, AND APPARENT HORIZONTAL AND RETROVERTED ACETABULAR COMPONENT. THE CUP, HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. 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
    283325 MAGNUM TRISPIKE CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 226060

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R