BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOD ARTHRO NL 1CM DIASL CNCTR

    MDR report key: 9580989 · Received January 13, 2020

    Report

    Report Number
    0001825034-2020-00231
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    July 9, 2019
    Report Date
    May 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00880304083028
    PMA / PMN Number
    K042409
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, ASSOCIATED REPORTS: 0001825034-2020-00231 AND 0001825034-2020-02071. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND THE RETURNED DEVICE. 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. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THE CONNECTOR FRACTURED AND INTENTIONALLY CUT ON THE PORTION THAT CONNECTS TO THE STEM. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00231 AND 0001825034-2020-00232. CONCOMITANT MEDICAL PRODUCTS: MOD ARTHRO 7 DEG LCK COLLAR, CATALOG#: CP260602, LOT#: 968130. MOD ARTHRO NL 1 CM DIASL CNCTR, CATALOG#: CP260605, LOT#: 161950. OSS POROUS IM STEM 21.5 X 150, CATALOG#: 150400, LOT#: 360910. OSS POROUS IM STEM 18.5 X 225, CATALOG#: 150405, LOT#: 898500. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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
    42800 MOD ARTHRO NL 1CM DIASL CNCTR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 236860 00880304083028

    Patients

    Seq Age Sex Outcome Treatment
    1