BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL DIAM. 54

    MDR report key: 6138416 · Received December 1, 2016

    Report

    Report Number
    3005180920-2016-00625
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 1, 2016
    Report Date
    March 3, 2017
    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

    ON 09 DECEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THA REVISION IN A YOUNG MALE PATIENT AFTER 3.5 YEARS. THE WELL DOCUMENTED RADIOGRAPHICAL HISTORY DESCRIBES A TYPICAL DISTAL FIXATION CASE. THE PATIENT HAS A PRONOUNCED DORR TYPE-A FEMORAL SHAPE, KNOWN AS THE MOST DIFFICULT TO TREAT WITH STRAIGHT CEMENTLESS STEMS, AND THE LOAD TRANSFER WAS TAKING PLACE ALONG A VERY SHORT AREA IN THE FEMORAL CANAL. ALREADY IN (B)(6) 2013 THE FIRST SIGNS OF DISTAL FIXATION CAN BE SEEN, BUT LITTLE REMEDY COULD BE TAKEN. THE CAUSE FOR THIS REVISION IS PROGRESSIVE DISTALIZATION OF LOAD TRANSFER AREA; IT DOES NOT APPEAR TO BE A DEVICE FAULT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 25 NOVEMBER 2016. LOT 125504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2013. EXPIRATION DATE: 2018-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMISTEM H, HA COATED STEM 4 STD, CODE 01.18.134, LOT. 124052 (K093944) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 DECEMBER 2012. EXPIRATION DATE: 2017-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET EXPLANTED.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT, IT WAS REPORTED THAT THE REVISION SURGERY WILL BE PERFORMED. TO DATE, NO UPDATES WERE RECEIVED DESPITE OF REGULAR REQUESTS BY MEDACTA. ON 16 FEBRUARY 2017 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 PRESENTED MECHANICAL PAIN. INFECTION WAS NOT VISIBLEREVISION DATE HAS NOT BEEN FIXED YET, BUT IT WILL NOT BE PREVENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789785 VERSAFITCUP CC TRIO ACETABULAR SHELL DIAM. 54 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 125504

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention