BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 56MM O.D. X 50 I.D.

    MDR report key: 5984130 · Received September 28, 2016

    Report

    Report Number
    0001825034-2016-03846
    Event Type
    Injury
    Date Received
    September 28, 2016
    Report Date
    July 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-03843 / 03844 / 03845 / 03846 / 03847 / 03848 / 03849 / 03850).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - M2A MAGNUM FEMORAL HEAD CATALOG#: 157450 LOT#: 193270, M2A MAGNUM TAPER ADAPTER CATALOG#: 139258 LOT#: 815520, TAPERLOC FEMORAL STEM CATALOG#: 103204 LOT#: 957930. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    OPERATIVES NOTES RECIEVED CONFIRM THE REPORTED EVENT THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISCLOCATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    OPERATIVE RECORD RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT A LEFT HIP CLOSED REDUCTION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635981 M2A MAGNUM PF CUP 56MM O.D. X 50 I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 395470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R