BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT

    MDR report key: 6547271 · Received May 5, 2017

    Report

    Report Number
    3005180920-2017-00235
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    April 6, 2017
    Report Date
    June 2, 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

    ON 12 MAY 2017 THE MANUFACTURER OF THE CERAMIC LINER INVOLVED IN THE COMPLAINT (NOT MARKETED IN US) PROVIDED A DOCUMENT REVIEW, REPORTING AS FOLLOWS: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NOT INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 04 MAY 2017 AND INCLUDES: ASA 2 PATIENT. ALL THE IMPLANTS WERE TAKEN OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017. THE SURGEON STATED THAT THE STEM HAS PROBABLY BEEN IMPLANTED WITH TOO MUCH ANTEVERSION WHAT CREATED AN IMPINGEMENT. WITH THE TIME THE LINER (NON-MEDACTA PRODUCT) BROKE AT HIS POSTERIOR BOARDER AND THE DEBRIS LINKED TO THE STEM LOOSENING. ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TEN YEARS AFTER PRIMARY CEMENTLESS THA, AN ASA 2 MALE PATIENT IS SUFFERING OF PAIN AND THE STEM IS REVISED. RADIOLUCENT LINES ARE VISIBLE RATHER EXTENSIVELY AROUND THE STEM, REASON UNKNOWN. ACCORDING TO REPORT, IMPINGEMENT OF THE STEM NECK WITH CERAMIC LINER WAS FOUND AT REVISION WITH LINER FRACTURE. IMPINGEMENT OF THE STEM NECK WITH A LONG LEVER ARM MAY HAVE CONTRIBUTED TO MECHANICAL LOOSENING OF THE STEM IN THE FEMUR, BUT NO FINAL DIAGNOSIS OF THE PROBLEM CAN BE CARRIED OUT WITH THE INFORMATION AT HAND. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 061164: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 SEPTEMBER 2006. EXPIRATION DATE: 2011-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330716 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 061164

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention