BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 48

    MDR report key: 10776898 · Received November 3, 2020

    Report

    Report Number
    3005180920-2020-00775
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807756
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 OCTOBER 2020. LOT 1902306: 200 ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2019. EXPIRATION DATE: 2024-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 190 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR EARLY LOOSENING OF THE ACETABULAR CUP IN CEMENTLESS PRIMARY THA ON A YOUNG WOMAN. THE ONLY AVAILABLE IMAGE SHOWS THE CUP ALREADY MOBILIZED, SO NO COMMENT CAN BE OFFERED AS TO THE INITIAL POSITION OF THE CUP. AN EARLY LOOSENING CAN BE DUE TO INSUFFICIENT PRIMARY STABILITY ACHIEVED AT THE TIME OF PRIMARY OPERATION, PERHAPS FOLLOWED BY EXCESSIVE STRESS DURING REHABILITATION. NO SIGN OF A DEFECTIVE IMPLANT IS DISCERNIBLE FROM THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    TILTING OF THE ACETABULAR CUP NOTED 3 MONTHS AFTER THE PRIMARY OPERATION BY A CONTROL X-RAY. THE SURGEON OFFERED THE PATIENT ANOTHER OPERATION TO REPOSITION THE CUP IN FEBRUARY, BUT THE PATIENT REFUSED BECAUSE SHE HAD NO PAIN. THE PAIN STARTED 2 MONTHS AGO AND SHE FINALLY ACCEPTED THE REVISION SURGERY. CUP, LINER AND HEAD HAVE BEEN SUCCESSFULLY REVISED 1 YEAR AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247132 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 48 ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 01.26.45.0048 1902306 07630030807756

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention