BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H STEM SIZE 4 STD

    MDR report key: 5398663 · Received January 29, 2016

    Report

    Report Number
    3005180920-2016-00010
    Event Type
    Injury
    Date Received
    January 29, 2016
    Date of Event
    December 31, 2015
    Report Date
    January 29, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11 JANUARY 2016 IT WAS COMMUNICATED THAT THE RESULT OF THE PATHOLOGY WAS NOT AVAILABLE. ON 18 JANUARY 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ACCORDING TO REPORT, THE ROOT CAUSE FOR THIS REVISION IS SHORT-TERM INFECTION, ALTHOUGH NO FINAL CONFIRMATION HAS BEEN RECEIVED. THERE ARE NO REASONS TO SUSPECT THAT THE ROOT CAUSE MAY HAVE BEEN DIFFERENT. STEM POSITIONING COULD PLAY A ROLE IN LONG TERM RESULTS BUT MORE UNLIKELY FOR SUCH A SHORT-TERM REVISION. ON 19 JANUARY 2016, CERAMTEC PROVIDED A DOCUMENT REVIEW FOR BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M (PRODUCT NOT REGISTERED IN THE USA) CONFIRMING THAT NO ISSUES WAS DETECTED. BATCH REVIEW OF MEDACTA IMPLANTS PERFORMED ON 27 JANUARY 2016. (B)(4). VERSAFITCUP ACETABULAR SHELL CC TRIO NO-HOLE Ø 56, CODE 01.26.45.1156, LOT. 151080 (K122911) (B)(4). VERSAIFTCUP CC FLAT PE HC LINER Ø 32 / F, CODE 01.26.3248HCT, LOT. 152086 (K103352) (B)(4). ON 27 JANUARY IT WAS CONFIRMED THAT THE PATHOGEN WILL NEVER BE AVAILABLE. ON 28 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION HERE REPORTED. ON 28 JANUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    EXPLANTATION OF TOTAL HIP IMPLANTS DUE TO SHORT TIME INFECTION. DURING THE REVISION ALL IMPLANTS HAVE BEEN REMOVED AND SEND TO SONICATION, THEREFORE THESE IMPLANTS WILL BE NOT SEND TO MEDACTA INTERNATIONAL SA FOR INVESTIGATION. X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57654 AMISTEM H STEM SIZE 4 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 153125

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention