BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

    MDR report key: 7685639 · Received July 13, 2018

    Report

    Report Number
    3005180920-2018-00504
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802133
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JULY 2018: LOT 081586: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 FEBRUARY 2008. EXPIRATION DATE: 30.06.2013 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 28 JUNE 2018 STEM REVISION OCCURRED 6 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A YOUNG MAN ((B)(6) AT TIME OF PRIMARY SURGERY). IN THE RADIOGRAPHIC IMAGE PROVIDED, SIGNS OF STRESS SHIELDING ARE VISIBLE AND THE STEM LOOKS SLIGHTLY UNDERSIZED. THE REASON OF THIS CHOICE MAY BE DUE TO PARTICULAR PATIENT ANATOMY OR BONE MORPHOLOGY BUT THIS CANNOT BE ASSESSED ON THE BASIS OF THE SINGLE POSTOPERATIVE ANTEROPOSTERIOR RADIOGRAPHIC PROJECTION RECEIVED. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY 6 YEARS AFTER PRIMARY DUE TO STEM LOOSENED OVER TIME: THE SIZE 1 LAT QUADRA-H WAS REVISED WITH A SIZE 3 QUADRA-H LAT. THIS REVISION WAS NOT DUE TO ANY ISSUES WITH THE IMPLANT ITSELF. THE OUTCOME OF THE CASE WAS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529210 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 081586 07630030802133

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention