BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 3801834 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03785
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    June 26, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2014 AT PATIENT'S REQUEST DUE TO PATIENT ALLEGED METAL-ON-METAL CONCERNS. DURING THE PROCEDURE, IT WAS NOTED THE ACETABULAR CUP WAS MALPOSITIONED. THE ACETABULAR CUP WAS REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2014 AT PATIENT'S REQUEST DUE TO PATIENT ALLEGED METAL-ON-METAL CONCERNS. DURING THE PROCEDURE, IT WAS NOTED THE ACETABULAR CUP WAS MALPOSITIONED. THE ACETABULAR CUP WAS REMOVED AND REPLACED WITH COMPETITOR PRODUCT. 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
    281446 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 504100

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R