BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48

    MDR report key: 8508149 · Received April 12, 2019

    Report

    Report Number
    3005180920-2019-00270
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 12, 2019
    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 08 APRIL 2019, LOT 161590: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2016. EXPIRATION DATE: 2021-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. ACETABULAR COMPONENT REVISION SURGERY IN A (B)(6) YEAR OLD WOMAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF BONE QUALITY ALTERATIONS AND AREAS OF REDUCED BONE DENSITY IN THE PROXIMAL PART OF THE ACETABULUM. THE RESULT OF THIS SITUATION WAS A CUP LOOSENING WITH CONSEQUENT INSTABILITY OF THE JOINT. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO CUP MOBILIZATION, 2 YEARS AND 4 MONTHS AFTER PRIMARY. THE CUP HAS BEEN REPLACED WITH DOUBLE MOBILITY SYSTEM, INLAY AND HEAD HAVE BEEN REPLACED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303955 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48 HIP ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 161590 07630030807756

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention