BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP DM TRIAL LINER MONOBLOC DMF-M

    MDR report key: 20155191 · Received September 6, 2024

    Report

    Report Number
    3005180920-2024-00716
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971246010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 AUGUST 2024: LOT 1954280: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. INVESTIGATION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER ON 3 SEPTEMBER 2024: FROM THE RECEIVED IMAGES, NO ADDITIONAL INFORMATION RELATED TO THE EVENT CAN BE OBTAINED, EXCEPT THAT THE PART APPEARS VISIBLY WORN, PROBABLY DUE TO THE HIGH USAGE OF THE COMPONENT. IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, BUT A POSSIBLE REASON COULD BE AN EXCESSIVE WEAR OF THE INSTRUMENT TOGETHER WITH A SUBOPTIMAL HANDLING/MAINTENANCE OF THE INSTRUMENT (DURING TRANSPORT OR WASHING), OR FORCES APPLIED ON THE METAL COMPONENT DURING THE USAGE.

    Description of Event or Problem · 0

    THE TRIAL LINER MONOBLOC DMF-MMETAL RING CAME OFF DURING HIP TRAILING. THE TRIAL COULD STILL BE USED BUT WAS NOT EASILY IDENTIFIABLE DURING X-RAY FOR ORIENTATION. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073050 VERSAFITCUP DM TRIAL LINER MONOBLOC DMF-M INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 1954280 07630971246010

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other