BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM SIZE 3 LAT

    MDR report key: 5250528 · Received November 25, 2015

    Report

    Report Number
    3005180920-2015-00288
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    October 26, 2015
    Report Date
    February 19, 2016
    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 22 JANUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 25 JANUARY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 03 NOV 2015 IT WAS COMMUNICATED THAT THE PATHOGEN IS STAPHYLOCOCCUS AUREUS AND THAT THE IMPLANTS WILL NOT BE AVAILABLE FOR INVESTIGATION. BATCH REVIEW PERFORMED ON 25 NOVEMBER 2015: QUADRA H CEMENTLESS, HA COATED LAT STEM # 3, CODE 01.12.033 LOT. 150992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MAY 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. VERSAFITCUP CC FLAT PE HC LINER Ø 36 / F, CODE 01.26.3648HCT LOT. 152090 (K103352): LOT 152090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. VERSAFITCUP CC TRIO NO HOLE ACETABULAR SHELL Ø 56, CODE 01.26.45.1156 LOT. 153631 (K122911): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. CERAMIC HEAD MANUFACTURED BY (B)(4) AND NOT MARKETED IN THE USA. DOCUMENT REVIEW PERFORMED BY THE MANUFACTURER WITHOUT ANY ISSUE DETECTED. ON 25 NOV 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING COMMENT: THIS CASE AS REPORTED IS AN ASCERTAINED INFECTION. THERE ARE NO REASONS TO SUSPECT THAT THE ROOT CAUSE MAY BE IN ANY WAY RELATED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    A REVISION SURGERY IS PLANNED FOR (B)(6) 2015 DUE TO INFECTION. ALL HIP COMPONENTS WILL BE REMOVED AND SUBSTITUTED WITH A SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780308 QUADRA H CEMENTLESS STEM SIZE 3 LAT FEMORAL CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 150992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention