BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z NAIL CMF 10MMX21.5CM 125 L

    MDR report key: 16183233 · Received January 17, 2023

    Report

    Report Number
    0009613350-2023-00014
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    October 3, 2022
    Report Date
    January 17, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HWC
    UDI-DI
    00889024585959
    PMA / PMN 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). CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: Z NAIL CMF 10.5 X 90 LAG SCR, ITEM#: 47249909010, LOT#3083326. REPORT SOURCE: JAPAN. 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 AND 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. CURRENTLY STILL IMPLANTED.

    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 PATIENTS CONDITION. NO FURTHER OUTCOME WAS REPORTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370209 Z NAIL CMF 10MMX21.5CM 125 L TRAUMA PROSTHESIS HWC ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3052830 00889024585959

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose