BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56

    MDR report key: 10288603 · Received July 17, 2020

    Report

    Report Number
    3005180920-2020-00446
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807794
    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 09 JULY 2020: LOT 1905157: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2019. EXPIRATION DATE: 2024-09-29. 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 ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 09 JULY 2020: STEM: AMISTEM C 01.18.102 CEMENTED LAT STEM SIZE 2 (K103189) LOT. 1905972A. LOT 1905972A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JAN-2020. EXPIRATION DATE: 2024-10-14. 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 MANAGER: HIP REVISION SURGERY PERFORMED 6 MONTHS AFTER PRIMARY HYBRID TOTAL HIP ARTHROPLASTY IN AN ELDERLY WOMAN ((B)(6) YEARS OLD) DUE TO AN ACETABULAR FRACTURE. NO TRAUMATIC EVENT WAS REPORTED. THE FRACTURE PROBABLY OCCURRED DURING ACETABULAR PREPARATION AND CUP IMPACTION AND MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. IN THIS CASE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY 6 MONTHS POST PRIMARY SURGERY FOR ACETABULAR FRACTURE. DURING THE REVISION ALSO STEM CAME OUT, SO THE SURGEON DECIDED TO REVISE ALL JOINT COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755786 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56 ACETABULAR COMPONENT LZO MEDACTA INTERNATIONAL SA 01.26.45.0056 1905157 07630030807794

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention