BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50

    MDR report key: 5586435 · Received April 19, 2016

    Report

    Report Number
    3005180920-2016-00173
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    March 22, 2016
    Report Date
    July 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 APRIL 2016: LOT 143429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2014. EXPIRATION DATE: 2019-06-30. 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 18 APRIL 2016 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS WHILE CHECKING THE X-RAY: THA REVISION 1,5 YEARS AFTER PRIMARY. ACCORDING TO REPORT, A POSSIBLE CAUSE IN THE SURGEON'S OPINION WAS THE EXCESSIVE LENGTH OF THE TWO SCREWS USED TO STABILIZE THE ACETABULAR CUP. THIS IS POSSIBLE BUT THERE IS NO INDICATION THAT THIS IS THE ROOT CAUSE. IN THE ONLY PROJECTION AVAILABLE, THE SCREWS LOOK A LITTLE LONG BUT CORRECTLY IMPLANTED; IT IS POSSIBLE THAT THEY WERE MISPLACED BUT THIS COULD ONLY BE VERIFIED IN A LATERAL PROJECTION. A RATHER LONG SCREW IS NOT NECESSARILY A CAUSE FOR PAIN. THE ROOT CAUSE FOR THIS FAILURE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 20 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN IN THE HIP. PROBABLY BOTH THE SCREWS ARE TOO LOONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241528 VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 143429

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention