BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APS KIT

    MDR report key: 12690030 · Received October 25, 2021

    Report

    Report Number
    0001825034-2021-02945
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 28, 2021
    Report Date
    January 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PZT
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PRODUCT WAS RETURNED OPENED. VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND THE INNER STERILE SEAL WAS OPENED. THERE IS ADHESIVE RESIDUE ON THE BLISTER FLANGE INDICATING THE PACKAGING WAS SEALED DURING MANUFACTURING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE OR CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET CANNOT BE DETERMINED, AS THE PRODUCT WAS RETURNED OPENED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. HAS NOT YET BEEN RETURNED.

    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 SURGERY WAS PERFORMED WITH APS APPROXIMATELY A MONTH AGO. WHEN THE PACKAGED WAS OPENED IT WAS FOUND THAT THE STERILE PACKAGE HAD ALREADY BEEN OPENED. SUBSEQUENTLY, ANOTHER APS WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592543 APS KIT BIOLOGICS PZT ZIMMER BIOMET, INC. N/A 021293

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown