BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 10.5 X 95 LAG SCR

    MDR report key: 15623895 · Received October 18, 2022

    Report

    Report Number
    0009613350-2022-00524
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 26, 2022
    Report Date
    January 3, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HWC
    UDI-DI
    00889024586581
    PMA / PMN Number
    N/A
    Removal / Correction 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). CONCOMITANT MEDICAL PRODUCTS: Z NAIL CMF 10MMX21.5CM 125 R LOT#3071179 ITEM#47249821010. FOREIGN SOURCE: JAPAN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2022-00526.

    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, D9, G3, G6, H1, H2, H3, 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. TWO UNDATED X-RAY IMAGES ARE AVAILABLE. THE IMAGES SHOW WHAT APPEARS TO BE A BACKING-OUT OF THE LAG SCREW. 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 APPROXIMATELY THREE (3) MONTHS AFTER IMPLANTATION, DURING A ROUTINE POST-OPERATIVE CHECKUP, IT WAS FOUND OUT THAT THE LEG SCREW HAD MIGRATED TO THE OUTER SIDE. 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
    359641 Z NAIL CMF 10.5 X 95 LAG SCR HIP PROSTHESIS HWC ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3069486 00889024586581

    Patients

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