BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 46

    MDR report key: 5822395 · Received July 26, 2016

    Report

    Report Number
    3005180920-2016-00383
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 26, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 JULY 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: MEDIAL CUP MIGRATION IN A THA PERFORMED LESS THAN ONE YEAR BEFORE. THE ONLY AVAILABLE X-RAY IS PRE-REVISION, HENCE NO EVALUATION IS POSSIBLE OF THE STATUS OF THE MEDIAL WALL AFTER PRIMARY. MIGRATION IN SPITE OF THE ADDITIONAL SCREW. NO REASON TO THINK THAT THE PROBLEM WAS ORIGINATED BY A DEFECTIVE DEVICE. BATCH REVIEW PERFORMED ON 22 JULY 2016. LOT 151054: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2015. EXPIRATION DATE: 2020-04-30. 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. ON 22 JULY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT. ON 25 JULY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS DUE TO THE CUP PROTRUDING INTO THE ACETABULUM. THE SURGEON REVISED THE CUP, THE LINER AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475854 VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 46 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 151054

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention