BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM (TM) MODULAR HEAD

    MDR report key: 6312901 · Received February 8, 2017

    Report

    Report Number
    0001825034-2017-00529
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 7, 2016
    Report Date
    January 19, 2018
    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
    FL, 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. CONCOMITANT PRODUCTS- 139252 M2A-MAGNUM 42-50MM TPR INSRT-6 110870. US157850 M2A-MAGNUM PF CUP 50ODX44ID 690670; (B)(4)TAPERLOC HA/PC 7.5MM T1 562390.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED DUE TO OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT HIP WAS REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO INFECTION. MEDICAL RECORDS INDICATES THE PATIENT WAS REVISED DUE TO PAIN, METAL ON METAL AND LOOSENING. CORROSION WAS NOTED ALONG THE TRUNNION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP WAS REVISION APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN. MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED DUE TO INTRACTABLE PAIN AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, CORROSION WAS NOTED ON THE TRUNNION; HOWEVER, THERE WAS NO EVIDENCE OF METALLOSIS OR STAINED TISSUE. THE FEMORAL HEAD WAS REMOVED AND REPLACED AND A POLYETHYLENE LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93235 M2A MAGNUM (TM) MODULAR HEAD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 053540

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R