BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIT E LINER-R-SZ 4-8MM

    MDR report key: 19661401 · Received July 2, 2024

    Report

    Report Number
    1038671-2024-02285
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 21, 2024
    Report Date
    April 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    PMA / PMN Number
    K232002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: A899216 350-24-24 - VIT E LINER-R-SZ 4-8MM A274758 350-02-04 - TALAR IMPLANT SZ 4 RT A747592 350-10-04 - ANKLE SZ 4 LOCKING CLIP A790605 350-12-04 - TIBIAL PLATE FB SZ 4 RT 066164 351-91-03 - RECIP SAWBLADE 8X50X1MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    APPROXIMATELY 2 MONTHS AFTER A RIGHT TOTAL ANKLE REPLACEMENT, THE PATIENT WAS REVISED DUE TO INFECTION. THE POLY WAS REVISED. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. NO PRODUCT RETURNING AS IT IS UNAVAILABLE. NO DEVICE IMAGES WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785341 VIT E LINER-R-SZ 4-8MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention SEE H11.