BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 54

    MDR report key: 9489460 · Received December 18, 2019

    Report

    Report Number
    3005180920-2019-01092
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807909
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 9-DEC-2019. LOT 1902319: 100 ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2019. EXPIRATION DATE: 2024-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 79 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    5 DAYS POST-OP PATIENT PRESENTED WITH ACETABULAR FRACTURE OF THE MEDIAL WALL CAUSING THE CUP LOOSENING. ALL IMPLANTS WERE REVISED. THERE IS NO DEFINITIVE REASON FOR THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283434 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 54 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 1902319 07630030807909

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention