BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM SIZE 4 STD

    MDR report key: 5070980 · Received September 11, 2015

    Report

    Report Number
    3005180920-2015-00193
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    August 12, 2015
    Report Date
    December 3, 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 03 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 05 NOV 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 SEPTEMBER 2015: LOT 090628: (B)(4) STEMS MANUFACTURED AND RELEASED ON 25 MAY 2008. EXPIRATION DATE: 2014-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) STEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. IT WAS COMMUNICATED THAT: THE IMPLANTS HAVE BEEN SEND TO (B)(4). WE DON'T RECIVE THEM BACK FOR INVESTIGATION. IT IS THE SECOND REVISION. THE FIST REVISION TOOK PLACE ON (B)(6) 2010 DURING WHICH THE SURGEON CHANGED THE CUP, INLAY AND HEAD. WE DIDN'T RECEIVE INFORMATION ABOUT THIS REVISION, UP TO NOW. BATCH REVIEW PERFORMED ON 08 SEPTEMBER ALSO ON THE OTHER THREE EXPLANTED ITEMS, THAT WERE IMPLANTED ON (B)(6) 2010: COCR FEMORAL HEADS CODE 01.25.022 (K072857) LOT 073385: (B)(4) HEADS MANUFACTURED AND RELEASED ON 02 APRIL 2008. EXPIRATION DATE: 2013-02-28. 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 LINER CODE 01.26.3244HCT (K103352) LOT 093082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 FEBRUARY 2010. EXPIRATION DATE: 2014-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. VERSAFITCUP CC SHELL CODE 01.26.56MBT (NOT MARKETED IN THE USA) LOT 100344: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MAY 2010. EXPIRATION DATE: 2015-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 18 AUGUST IT WAS CONFIRMED THAT THE PATHOGE WAS UNKNOWN.

    Description of Event or Problem · 1

    REVISION SURGERY 6 YEARS AFTER PRIMARY DUE TO AN INFECTION. ALL THE IMPLANTS WERE EXPLANTED, THEY ARE NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602868 QUADRA H FEMORAL STEM SIZE 4 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 090628

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention