BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 3790818 · Received May 5, 2014

    Report

    Report Number
    0001825034-2014-03581
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 3, 2014
    Report Date
    April 11, 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
    MI, 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01487 & 03581 / 03582).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT HAD TO BE REVISED ON (B)(6) 2014, DUE TO DISCOMFORT, NOISE AND ELEVATED METAL IONS. PATIENT HAS MET WITH THE LEGAL DEPARTMENT BUT NO SUIT HAS BEEN FILED. ADDITIONAL INFORMATION RECEIVED IN THE REVISION OPERATIVE REPORT NOTED THE RIGHT HIP REVISION WAS DUE TO PAIN AND ELEVATED METAL ION LEVELS AND NOTED THE PRESENCE OF FLUID AND A PSEUDOCYST. OPERATIVE REPORT FURTHER NOTED THAT THERE WERE NO SIGNS OF METAL-ON-METAL WEAR AND THAT THE ACETABULAR CUP WAS WELL-FIXED. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266325 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 091800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R