BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 3821822 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04446
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    July 28, 2010
    Report Date
    July 9, 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
    ND, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. 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: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. " THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND REVISION PROCEDURES ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN AND PERSONAL INJURY. 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 PATIENT REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND REVISION PROCEDURES ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN AND PERSONAL INJURY. 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 RIGHT HIP REVISION ON (B)(6) 2010 DUE TO PAIN, ELEVATED ESR AND CRP AND A LOOSE ACETABULAR COMPONENT. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF JOINT FLUID, NO PUS, HETEROTOPIC BONE, A SUPERIOR LATERAL DEFECT AND FIBROUS TISSUE. THE ACETABULAR CUP WAS REMOVED AND AN ANTIBIOTIC SPACER MOLD WAS PLACED. AN ADDITIONAL REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 WHERE THE STEM AND MODULAR HEAD WERE REMOVED. ALL COMPONENTS WERE REPLACED WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299704 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 854160

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R