BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO FLAT PE LINER 32 / E

    MDR report key: 11169837 · Received January 14, 2021

    Report

    Report Number
    3005180920-2021-00046
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 18, 2020
    Report Date
    February 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807589
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D PROJECT MANAGER: FROM THE RECEIVED PIECE, PARTICULAR SCRETCHES AND DAMAGES WERE NOTICED ON A PORTION OF THE RIM OF THE LINER; LIKELY DUE TO A REPEATED CONTACT WITH THE NECK STEM; IN PARTICULAR, THE THICKNESS OF A REGION OF THE RIM WAS MINOR RESPECT TO THE OPPOSITE SIDE PROBABLY DUE TO THE PATIENT BODY LOAD. THERE IS NO SUSPECT OF THE PRESENCE OF A THIRD BODY AS THE SURFACE OF THE BALL HEAD APPEARED TO BE NOT PARTICULAR WORN.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 DECEMBER 2020: LOT 143438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-SEP-2014. EXPIRATION DATE: 2019-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. THE DEVICE ANALYSIS WILL BE PERFORMED ON THE THIRD WEEK OF JANUARY WHEN THE R&D PROJECT MANAGER WILL BE IN THE OFFICE AND THE ANALYSIS CAN BE DONE ON THE DEVICE.

    Description of Event or Problem · 1

    WORN INLAY OF A VERSAFITCUP CC TRIO IMPLANTED ON 2014, OSTEOLYSIS IN THE FEMUR. REVISION PERFORMED ON (B)(6) 2020 (6 YEARS AND 2 MONTHS AFTER PRIMARY), LINER AND HEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70739 VERSAFITCUP CC TRIO FLAT PE LINER 32 / E HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 01.26.3244STT 143438 07630030807589

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention