BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø 56

    MDR report key: 6646021 · Received June 16, 2017

    Report

    Report Number
    3005180920-2017-00315
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 16, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 AND INCLUDES: THE PATIENT HAD SOME TYPE OF SYNDROME THAT CAUSED THE ANATOMY TO NOT BE NORMAL. ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: INTRAOPERATIVE ACETABULAR FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL HIP REPLACEMENTS, DESCRIBED AND QUANTIFIED IN LITERATURE. THEY MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. IN THIS CASE, ACCORDING TO THE REPORT, THE ACTEABULAR COMPONENT WAS WELL FIXED AND DIDN'T REQUIRE ANY ADDITIONAL PROCEDURE. THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 161584: 69 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. THE CUP WAS LEFT IN PLACE, NOT EXPLANTED.

    Description of Event or Problem · 1

    AFTER IMPACTION OF THE CUP, THE SURGEON NOTICED THE ACETABULAR WALL HAD FRACTURED. THE CUP WAS WELL FIXED. NO ADDITIONAL IMPLANTS NEEDED, NO REVISION IS REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427187 VERSAFITCUP ACETABULAR SHELL Ø 56 CEMENTLESS ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 161584

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other