BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI TIB TRAY SZ B LM PMA

    MDR report key: 8366291 · Received February 25, 2019

    Report

    Report Number
    3002806535-2019-00147
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    January 21, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT (DAMAGED POUCH) HAS BEEN CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED PACKAGING, WHICH CONFIRMS THE INNER STERILE BARRIER (POUCH) IS DAMAGED. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE TRANSIT DAMAGE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    INNER STERILE PACKAGING OPEN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INNER STERILE PACKAGING DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160720 OXF UNI TIB TRAY SZ B LM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 2448172

    Patients

    Seq Age Sex Outcome Treatment
    1