BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 1970252 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00016
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    June 23, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST CASE OF REVISION DUE TO ASEPTIC STEM LOOSENING INVOLVING THE FEMORAL STEM REFERENCE (B)(4). DOCUMENT REVIEW: QUADRA H. FEMORAL STEM SIZE 1 - (B)(4)/LOT 090163 (45 PIECES PRODUCED/41 PIECES IMPLANTED). COCR FEMORAL BALL HEAD 28 - REF. (B)(4)/LOT 082619 (50 PIECES PRODUCED/45 PIECES IMPLANTED). VERSAFITCUP DOUBLE MOBILITY LINER - REF. (B)(4)/LOT 083747 (26 PIECES PRODUCED/20 PIECES IMPLANTED). ALL PARAMETERS FOR THE THREE LOTS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLES FOR METAL COMPONENTS WERE RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO INCIDENTS HAVE BEEN REPORTED UP TO NOW INVOLVING OTHER PIECES OF THE THREE LOTS. THE RETURNED PIECES WERE ANALYZED, NO FINDING CONCERNING THE BALL HEAD AND THE LINER. THE FEMORAL STEM SHOWS EVIDENT SIGNS OF HITS, THIS MEANS THAT THE SURGEON HAD TO USE A TOOL TO FACILITATE THE EXPLANTATION OF THE STEM. ON THE BASIS OF THE INFORMATION COLLECTED NO CONCLUSION CAN BE DRAWN. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. STEM LOOSENING IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY. THERE IS NO EVIDENCE THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED DUE TO THE ASEPTIC STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 1 STANDARD JDI MEDACTA INTERNATIONAL SA NA 090163

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT # 082619| COCR FEMORAL BALL HEAD 28: (B)(4)| LOT # 083747| VERSAFITCUP DM LINER: REF. (B)(4)