BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3910186 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05924
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    July 29, 2011
    Report Date
    October 18, 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
    SC, 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 THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: MATERIAL SENSITIVITY REACTIONS. WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.

    Additional Manufacturer Narrative · 1

    CORRECTION: PATIENT UNDERWENT FEMORAL RESURFACING PROCEDURE INITIAL AND NOT TOTAL HIP ARTHROPLASTY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED DATA: EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2011 DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION. ADDITIONAL INFORMATION NOTED GREY METALLOSIS, WEAR, AND FLUID COLLECTION AT TIME OF REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION. ADDITIONAL INFORMATION NOTED GREY METALLOSIS, WEAR, AND FLUID COLLECTION AT TIME OF REVISION. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP WAS REMOVED AND REPLACED DURING THE REVISION SURGERY.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION. ADDITIONAL INFORMATION NOTED GREY METALLOSIS, WEAR, AND FLUID COLLECTION AT TIME OF REVISION. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP WAS REMOVED AND REPLACED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387337 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 219190

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R