BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSTRIDE APS KIT WITH ACD-A

    MDR report key: 8338859 · Received February 14, 2019

    Report

    Report Number
    0001825034-2019-00609
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    December 12, 2018
    Report Date
    May 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PZT
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT RECEIVED AN INJECTION IN THEIR RIGHT KNEE. THE PATIENT WAS HOSPITALIZED APPROXIMATELY 7 DAYS LATER FOR AN INFECTION OF THE RIGHT KNEE AND TREATED WITH ANTIBIOTICS AND SYNOVECTOMY OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134501 NSTRIDE APS KIT WITH ACD-A HAEMATOLOGICAL CONCENTRATE SYSTEM PZT ZIMMER BIOMET, INC. N/A 702061

    Patients

    Seq Age Sex Outcome Treatment
    1