BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM

    MDR report key: 5053403 · Received September 3, 2015

    Report

    Report Number
    3005180920-2015-00186
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    August 4, 2015
    Report Date
    December 2, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND IN THE FOLLOW UP #1. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2015: LOT 092853: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 FEBRUARY 2010. EXPIRATION DATE: 2015-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON AUG, 11TH 2015 WE WERE INFORMED THAT THE X-RAYS WERE NOT AVAILABLE AND THAT THE INVOLVED ITEMS WERE UNDER MICROBIOLOGICAL INVESTIGATION. ON SEPTEMBER 03RD 2015 IT WAS COMMUNICATED THAT WE ARE STILL WAITING FOR INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 11 SEPTEMBER 2015 WE RECEIVED THE INFORMATION THAT THE INFECTION WAS NOT CONFIRMED. ON 06 OCTOBER 2015 IT WAS COMMUNICATED THAT THE EXPLANTED ITEMS ARE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    REVISION SURGERY FOR STEM LOOSENING, SUSPICION OF INFECTION, 5 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583679 QUADRA H CEMENTLESS STEM CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 092853

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention