BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF TIB RESECTOR STYLUS ASSY SIZE 3MM

    MDR report key: 6157799 · Received December 9, 2016

    Report

    Report Number
    3002806535-2016-00890
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 25, 2016
    Report Date
    March 28, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. THE PRODUCTS WERE TESTED FOR HARDNESS AND WERE CONFORMING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    DURING A KNEE HEMI ARTHROPLASTY THE TIBIAL RESECTOR FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814098 OXF TIB RESECTOR STYLUS ASSY SIZE 3MM PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A ZB160401

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR