BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFILL BONE SUBSTITUTE MATERIAL

    MDR report key: 19760298 · Received July 17, 2024

    Report

    Report Number
    3008812173-2024-00002
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 24, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    MQV
    UDI-DI
    00889024205123
    PMA / PMN Number
    K190814
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 414.502; LOT# 209517423. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THERE IS A HOLE ON THE RIGHT SIDE OF THE PACKAGING; HOWEVER, THE LEFT SIDE APPEARS TO HAVE BEEN TORN WHEN OPENED AND NOT RETURNED. THE OUTER CARTON WAS NOT RETURNED TO RULE OUT TRANSIT DAMAGE. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS CONFIRMED THAT THERE IS A HOLE AND DAMAGED TO THE POUCH; HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION 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

    IT WAS REPORTED THAT DURING A PROCEDURE, THE INNER PACKAGING OF THE SCP CANNULA HAD A HOLE IN IT. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED FOR THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505426 ACCUFILL BONE SUBSTITUTE MATERIAL FILLER, BONE VOID, CALCIUM COMPOUND MQV ZIMMER KNEE CREATIONS, INC. NI 50175 00889024205123

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female