BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 10MMX21.5CM 125 L

    MDR report key: 15561002 · Received October 7, 2022

    Report

    Report Number
    0009613350-2022-00517
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    September 8, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ZIMMER MANUFACTURING SWITZERLAND GMBH
    Product Code
    HSB
    UDI-DI
    00889024585959
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCTS; Z NAIL CMF 10.5 X 90 LAG SCR , ITEM# 47-2499-090-10 , LOT# 3083326. REPORT SOURCE-FOREIGN - JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2022-00515. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H6, H10. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION RELATED TO THE EVENT. THE PROVIDED X-RAY PICTURE CONFIRMS THE REPORTED EVENT. NO SURGICAL REPORTS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. A FURTHER AND MORE COMPREHENSIVE INVESTIGATION WAS CARRIED OUT AS PART OF A CAPA, WHICH DETERMINED THAT NO POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE REQUIRED. THIS DECISION WAS BASED ON THE CONCLUSIONS FROM LITERATURE REVIEW, COMPLAINT REVIEW FROM HCP, AND CURRENT ACCEPTABLE PERFORMANCE OF THE ZNN FORTIS WITH TLS. 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 2 WEEKS POST-IMPLANTATION, IT WAS CONFIRMED BY X-RAYS THAT THE LAG SCREW WAS SLIDING TO OUTER SIDE. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. REVISION SURGERY IS NOT CURRENTLY PLANNED. NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. 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
    2466660 Z NAIL CMF 10MMX21.5CM 125 L TRAUMA PROSTHESIS HSB ZIMMER MANUFACTURING SWITZERLAND GMBH N/A 3052830 00889024585959

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other SEE H10 NARRATIVE.