BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOD ARTHRO 7 DEG LCK COLLAR

    MDR report key: 9580992 · Received January 13, 2020

    Report

    Report Number
    0001825034-2020-00232
    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
    00880304082991
    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

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE DEVICE DID NOT CONTRIBUTED TO THE REPORTED EVENT. THE INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE DEVICE DID NOT CONTRIBUTED TO THE REPORTED EVENT. THE INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED.

    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 NL 1 CM DIASL CNCTR, CATALOG#: CP260605, LOT#: 236860. 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
    42802 MOD ARTHRO 7 DEG LCK COLLAR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 968130 00880304082991

    Patients

    Seq Age Sex Outcome Treatment
    1