BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 6

    MDR report key: 16139671 · Received January 11, 2023

    Report

    Report Number
    3007963827-2023-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    January 5, 2023
    Report Date
    April 19, 2023
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024229891
    PMA / PMN Number
    K172524
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND BOTH BLISTERS ARE DEFORMED WHICH IS VISUALLY CONSISTENT WITH THERMAL DAMAGE. THE INNER STERILE BLISTER SEAL WAS MEASURED AND FOUND TO BE NON-CONFORMING TO INA 55-0000-310-01 SECONDARY TO THE THERMAL DAMAGE. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE PACKAGING OPERATOR NOT FOLLOWING THE WORK INSTRUCTIONS PROVIDED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STERILE PACKAGING WAS DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199842 FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 6 PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 65092949 00889024229891

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown