BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z NAIL CMF 10.5 X 90 LAG SCR

    MDR report key: 15678753 · Received October 27, 2022

    Report

    Report Number
    0009613350-2022-00564
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 3, 2022
    Report Date
    January 17, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HWC
    UDI-DI
    00889024586574
    PMA / PMN Number
    N/A
    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). REPORT SOURCE - JAPAN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. CURRENTLY STILL IMPLANTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: Z NAIL CMF 10MMX21.5CM 125 L ITEM#47249821110 LOT#3052830. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED: PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICES USED FOR TREATMENT. TWO X-RAY PICTURES WERE RETURNED FOR EVALUATION. ONE X-RAY SHOWS THE THAT THE LAG SCREW CHANGED ITS ORIGINAL POSITION. IT SEEMS LIKE THAT THE LAG SCREW WAS SLIDING TO OUTER SIDE. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00564, 0009613350 - 2023 - 00014. 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

    IT WAS REPORTED THAT 6 WEEKS POST-IMPLANTATION, IT WAS CONFIRMED THOUGH X-RAYS THAT THE LAG SCREW WAS SLIDING TO THE OUTER SIDE. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. NO FURTHER OUTCOME WAS REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    2944874 Z NAIL CMF 10.5 X 90 LAG SCR TRAUMA PROSTHESIS HWC ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3083326 00889024586574

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose