BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 2460968 · Received February 13, 2012

    Report

    Report Number
    3005180920-2012-00008
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 17, 2012
    Report Date
    February 13, 2012
    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

    DOCUMENT REVIEW: QUADRA H FEMORAL STEM SIZE 2 STD - REF 01.12.022 / LOT 082264 (52 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. AROUND 30 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. ON THE BASIS OF THE INFO COLLECTED, NO CONCLUSION CAN BE DRAWN. THE ROOT CAUSE OF THE EVENT IS UNK. 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

    STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 2 STANDARD JDI MEDACTA INTERNATIONAL, SA 082264

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention