BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSTRIDE APS KIT WITH ACD-A

    MDR report key: 10390324 · Received August 11, 2020

    Report

    Report Number
    0001825034-2020-03124
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 13, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PZT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H1, H2, H4, H6, H10. DEVICE HISTORY RECORD 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). REPORT SOURCE: FOREIGN: (B)(6). 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTENSE PAIN DURING THE PROCEDURE. THE PAIN BEGAN TO SUBSIDE AFTER THE PROCEDURE WAS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855182 NSTRIDE APS KIT WITH ACD-A BIOLOGICS KIT PZT ZIMMER BIOMET, INC. 191513

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O