BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL DIAM. 50

    MDR report key: 6224669 · Received January 5, 2017

    Report

    Report Number
    3005180920-2016-00709
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 7, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 14 DECEMBER 2016 AND INCLUDES: THE SURGEON PERFORMED REVISION SURGERY THROUGH THE ANTERIOR APPROACH ON 14 DECEMBER 2016. HEAD WAS REMOVED WITH HEAD IMPACTOR. CUP HAD INCREASED ANTEVERSION AND WAS EASY TO REMOVE AS LITTLE OSTEOINTEGRATION HAD OCCURRED. THE SURGEON FRESHENED UP WITH A 50/51MM REAMER, TRIALLED AND INSERTED 52MM CUP. TWO SCREWS WERE PLACED AND CUP WAS STABLE. HEAD SIZE 36S WAS REPLACED WITH A SIZE 36M. THERE WERE NO SIGNS OF INFECTION. BATCH REVIEW PERFORMED ON 29 DECEMBER 2016. LOT 160098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 APRIL 2016. EXPIRATION DATE: 2021-03-22. 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 03 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: MOBILIZATION OF THE ACETABULAR COMPONENT 6 MONTHS AFTER PRIMARY HYBRID THA IN AN ELDERLY WOMAN ((B)(6)). AVAILABLE X-RAYS SHOW THE PRESENCE OF A RADIOLUCENT LINE IN THE DISTAL PART OF THE ACETABULAR COMPONENT THAT NEVER ACHIEVED OSTEOINTEGRATION, PROBABLY BECAUSE OF THE POOR BONE QUALITY AND OLD AGE. THE SINGLE SCREW HELD BUT WAS NOT ABLE TO PREVENT CUP ROTATION. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS REVIEWED BY THE SURGEON AFTER COMPLAINING OF PAIN IN THE HIP. X-RAY SHOWED THAT THE CUP HAD TILTED INTO EXCESSIVE ANTEVERSION. A REVISION SURGERY WAS SCHEDULED TO CORRECT THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10309 VERSAFITCUP CC TRIO ACETABULAR SHELL DIAM. 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 160098

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention