BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO 01.26.45.0046 ACETABULAR SHELL CC TRIO Ø 46

    MDR report key: 18892728 · Received March 13, 2024

    Report

    Report Number
    3005180920-2024-00119
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807749
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 FEBRUARY 2024 LOT 160097: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2016. EXPIRATION DATE: 2021-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: REVISION OF THE CUP 7 YEARS AND 7 MONTHS AFTER INDEX SURGERY DUE TO MALPOSITION OF THE CUP AND IT WENT THROUGH THE INNER WALL OF THE ACETABULUM. ACCORDING TO REPORT, THE CUP BECAME LOOSE AND THEN PROTRUDED IN THE ACETABULAR WALL. POST-OP IMAGES AFTER THE INDEX SURGERY WERE NOT PROVIDED. LACK OF INFORMATION AND HISTORY PREVENTS A THOROUGH ANALYSIS TO BE PERFORMED. PROGRESSIVE MIGRATION OF THE CUP AFTER ALMOST 8 YEARS IS A RATHER UNUSUAL EVENT, HOWEVER IT MAY BE A CONSEQUENCE OF ASEPTIC LOOSENING, A PHENOMENON DESCRIBED IN LITERATURE, WHOSE CAUSES OFTEN REMAIN UNDETERMINED. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT 7 YEARS AND 7 MONTHS POST PRIMARY THE CUP PROTRUDED IN THE ACETABULAR WALL LEADING TO CUP DISSOCIATION FROM THE ACETABULAR BONE. THE SURGEON REVISED SUCCESSFULLY ALL THE ACETABULAR COMPONENTS AND THE BALL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191959 CUP: VERSAFITCUP CC TRIO 01.26.45.0046 ACETABULAR SHELL CC TRIO Ø 46 HIP ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 160097 07630030807749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention