BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX M2A MAGNUM MODULAR HEAD 40MM HEAD DIAMETER MINUS 6MM NECK

    MDR report key: 6045152 · Received October 20, 2016

    Report

    Report Number
    0001825034-2016-04219
    Event Type
    Injury
    Date Received
    October 20, 2016
    Report Date
    June 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04218 / 04219).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - TAPERLOC STEM ,CATALOG#: 15-103203, LOT#: 160290. M2A MAGNUM CUP, CATALOG#: US157846, LOT#: 698470. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT IS SCHEDULED FOR A LEFT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION BUT DID NOT INDICATE WHY A REVISION PROCEDURE WAS NECESSARY. NO REVISION HAS BEEN REPORTED TO DATE. 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
    696401 SELEX M2A MAGNUM MODULAR HEAD 40MM HEAD DIAMETER MINUS 6MM NECK PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 133530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R