BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 3163383 · Received June 11, 2013

    Report

    Report Number
    0001825034-2013-01901
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    March 5, 2009
    Report Date
    January 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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: "MATERIAL SENSITIVITY REACTIONS." AND "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02218, 1825034-2013-01901 & 01902). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY FURTHER PATIENT INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, METALLOSIS, AND DAMAGE TO SURROUNDING BONE/TISSUE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO LOOSENING OF THE ACETABULAR CUP. THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET MODULAR HEAD. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, METALLOSIS, AND DAMAGE TO SURROUNDING BONE/TISSUE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2009 DUE TO LOOSENING OF THE ACETABULAR CUP. THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET MODULAR HEAD. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF NEGATIVE EFFECTS TO TISSUE, BONES, MUSCLES AND LIGAMENTS. 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
    263671 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 309340

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R