BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 54

    MDR report key: 9914996 · Received April 2, 2020

    Report

    Report Number
    3005180920-2020-00204
    Event Type
    Injury
    Date Received
    April 2, 2020
    Date of Event
    March 3, 2020
    Report Date
    April 2, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807787
    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 13 MARCH 2020: LOT 123593: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2012. EXPIRATION DATE: 2017-09-30. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 13 MARCH 2020: AMISTEM H 01.18. (B)(4) HA COATED STD STEM SIZE 2 (K093944). LOT 120449: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2012. EXPIRATION DATE: 2017-03-31. 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. THE CUP LINER AND BALL HEAD EXPLANTED ARE NOT MARKETED IN THE USA. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: LATE INFECTION IN CEMENTLESS THA, 6 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 6 YEARS AFTER PRIMARY SURGERY, DUE TO INFECTION. ALL THE IMPLANTS HAVE BEEN SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378658 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 54 HIP ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0054 123593 07630030807787

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention