BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 LAT

    MDR report key: 6352736 · Received February 23, 2017

    Report

    Report Number
    3005180920-2017-00064
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    January 24, 2017
    Report Date
    February 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 31 JANUARY 2017 AND INCLUDES: ALL OTHER ITEMS ARE NON-MEDACTA PRODUCTS. ON 10 FEBRUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TOTAL REVISION OF A CEMENTLESS THA PERFORMED ON A MALE PATIENT, 7 YEARS AFTER PRIMARY SURGERY. IN THE PRIMARY CASE, A LARGE DIAMETER METAL HEAD, NOT MANUFACTURED BY MEDACTA, WAS USED ON A MEDACTA STEM IN COMBINATION WITH A NON-MEDACTA, UNKNOWN MONOBLOCK METAL CUP. ACCORDING TO REPORT, THE CAUSE FOR REVISION IS OSTEOLYSIS (VISIBLE ON THE X-RAY) CAUSED BY METALLOSIS. THE METALLOSIS EFFECT IS MOST LIKELY ORIGINATED AT THE TRIBOLOGICAL INTERFACE BETWEEN HEAD AND CUP. THE STEM SHOULD NOT BE CONSIDERED RESPONSIBLE FOR THIS ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED ON 17 FEBRUARY 2017 AND INCLUDES: THE SURGEON LEFT THE STEM IN PLACE AND REVISED HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEW PERFORMED ON 21 FEBRUARY 2017. LOT 090625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MAY 2009. EXPIRATION DATE: 2014-04-30. 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.

    Description of Event or Problem · 1

    THE SURGEON DETERMINED THE PATIENT HAD METALLOSIS AND PLANNED TO REVISE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134933 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 090625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention