BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 12MM

    MDR report key: 8704995 · Received June 17, 2019

    Report

    Report Number
    0001825034-2019-02602
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    December 19, 2017
    Report Date
    November 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: OSS POLY LOCK PIN; P/N: 150478, L/N: 104760. OSS TIBIAL POLY BEARING; P/N: 150410, L/N: 514550. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02601, 0001825034 - 2019 - 02602.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S POLY AND CONNECTING PIN WERE REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498572 OSS TIBIAL POLY BEARING 12MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 514550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R