BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS POROUS IM STEM 18.5 X 225

    MDR report key: 10079950 · Received May 21, 2020

    Report

    Report Number
    0001825034-2020-02071
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    July 9, 2019
    Report Date
    May 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00231. CONCOMITANT MEDICAL PRODUCTS: MOD ARTHRO 7 DEG LCK COLLAR CATALOG#: CP260602 LOT#: 968130, MOD ARTHRO NL 1CM DIASL CNCTR CATALOG#: CP260605 LOT#: 161950, OSS POROUS IM STEM 21.5 X 150 CATALOG#: 150400 LOT#: 360910, MOD ARTHRO NL 1CM DIASL CNCTR CATALOG#: CP260605 LOT#: 236860. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW FOUND THE STEM WAS WELL FIXED IN THE PATIENT. THE SURGEON TRIED TO REMOVE THE ALREADY FRACTURED DIAPHYSEAL CONNECTOR FROM THE STEM BUT COULDN¿T AND WAS NOTED AS AN INTRAOP COMPLICATION THAT DELAYED THE SURGERY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

    IT WAS REPORTED THAT DURING A REVISION OF A LEFT KNEE OSS SYSTEM DUE TO A BROKEN JUNCTION/CONNECTOR COMPONENT, THE SURGEON STATED THAT THE MORRIS TAPER COULD NOT BE BROKEN FROM THE FEMORAL STEM DESPITE MULTIPLE ATTEMPTS AND DIFFERENT INSTRUMENTS. THE SURGERY HAD TO BE MODIFIED TO CUT THE SEGMENTS APART, EXTENDING SURGICAL TIME BY AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544965 OSS POROUS IM STEM 18.5 X 225 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 898500

    Patients

    Seq Age Sex Outcome Treatment
    1