BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD

    MDR report key: 6310764 · Received February 8, 2017

    Report

    Report Number
    3005180920-2017-00027
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 9, 2017
    Report Date
    February 8, 2017
    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

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2017 AND INCLUDES: THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY AS PLANNED ON (B)(6) 2017. BATCH REVIEWS PERFORMED ON 06 FEBRUARY 2017. LOT 136015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø 46, CODE 01.26.45.1146, LOT. 135383 (K122911) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JANUARY 2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP FLAT PE HC LINER Ø 28 / C, CODE 01.26.2839HCT, LOT. 134662 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 DECEMBER 2013. EXPIRATION DATE: 2018-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 23 JANUARY 2017 THE MANUFACTURER OF THE CERAMIC COMPONENT INVOLVED IN THIS COMPLAINT (NOT MARKETED IN US) PROVIDED A DOCUMENT REVIEW WITH THE FOLLOWING OUTCOMES: THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION.

    Description of Event or Problem · 1

    HIP PAIN 2 YEARS AFTER FIRST SURGERY. AT THE BEGINNING THE SURGEON THOUGHT IT WAS A PROBLEM OF STEM LOOSENING BUT THE IMPLANTS WERE VERY WELL INTEGRATED. HE THOUGHT ABOUT A SUSPICION OF INFECTION SO THE SURGEON DECIDED TO CHANGE EVERYTHING. A REVISION WAS PLANNED. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95386 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 136015

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention