BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 6936517 · Received October 10, 2017

    Report

    Report Number
    0001825034-2017-07986
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    October 4, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. RITTER, MERRILL A. ¿FLAT-ON-FLAT, NONCONSTRAINED, COMPRESSION MOLDED POLYETHYLENE TOTAL KNEE REPLACEMENT.¿ CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, VOL. 321, 1995, PP. 79¿85.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "FLAT-ON-FLAT, NONCONSTRAINED COMPRESSION MOLDED POLYETHYLENE TOTAL KNEE REPLACEMENT". A PATIENT WAS IDENTIFIED IN THE ARTICLE FOR SURGERY DUE TO POSSIBLE LOOSE FEMUR ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714385 UNKNOWN KNEE KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R