BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 1

    MDR report key: 11473933 · Received March 12, 2021

    Report

    Report Number
    3005180920-2021-00196
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802027
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 141745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2014. EXPIRATION DATE: 2019-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT SINCE 2017. PRELIMINARY INVESTIGATION PERFOREMD BY MEDACTA R&D DEPARTMENT: LOOKING AT THE IMAGES PROVIDED OF THE EXPIANTED STEM IT IS VISIBLE THAT ALMOST THE WHOLE HA COATING HAS BEEN ABSORBED BY THE PATIENT BONE AS EXPECTED. A LOT OF SIGNS AND SCRATCHES ARE PRESENT ON THE NECK AND TAPER PARTS BUT IS REASONABLY POSSIBLE THAT THEY WERE CREATED DURING THE REVISION SURGERY. IT IS NOT POSSIBLE TO HYPOTHESIZE A DEFINED ROOT CAUSE. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFARIS DEPARTMENT: 3 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM IS LOOSE AND NEEDS REVISION. IT APPEARS TO BE COMPLETELY DEMARCATED BY RADIOLUCENT LINES ALL AROUND, ALTHOUGH THERE IS NO MENTION OF POSSIBLE INFECTIONS. THEREFORE WE MUST CATEGORIZE THIS EVENT AS AN ASEPTIC LOOSENING, ALTHOUGH THE RADIOGRAPHICAL APPEARANCE IS RATHER PECULIAR. NO FINAL CONCLUSION CAN BE REACHED; ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING THA, REPORTED IN LITERATURE, THOUGH THE LENGTH OF FOLLOW UP (RATHER SHORT) AND THE VISUAL APPEARANCE MAKE THIS CASE QUITE PARTICULAR.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO ASEPTIC STEM LOOSENING 2 YEARS 11 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373170 STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 1 FEMORAL CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.021 141745 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention