BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2

    MDR report key: 12878086 · Received November 26, 2021

    Report

    Report Number
    3005180920-2021-00917
    Event Type
    Injury
    Date Received
    November 26, 2021
    Date of Event
    October 28, 2021
    Report Date
    November 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802034
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 NOVEMBER 2021: LOT 081892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUGUST-2008. EXPIRATION DATE: 2013-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 13 YEARS AFTER PRIMARY CEMENTLESS THA AN EXTENSIVE RADIOLUCENT LINE SUROUNDS BOTH STEM AND CUP, AND THEY BOTH NEED REVISION. THE TRIBOLOGICAL PAIRING WAS CERAMIC ON CERAMIC, SO PE DEBRIS CANNOT BE SUSPECTED TO HAVE CAUSED THE REACTION. THE REPORT DOES NOT MENTION INFECTION BUT IT DOES NOT GIVE ELEMENTS TO EXCLUDE THAT A LOCAL INFLAMMATORY REACTION TOOK PLACE: THE SITUATION IS RATHER UNUSUAL, IN ABSENCE OF A SUBJECTIVE REACTIVE PROCESS. NO CONCLUSION CAN BE DRAWN TO DATE AS TO THE CAUSES OF THIS MOBILIZATION. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 04 NOVEMBER 2021. CUP: VERSAFITCUP CC LIGHT 01.26.48MBTL ACETABULAR SHELL CC LIGHT Ø 48 LOT. 080023 (ITEM NOT REGISTERED IN USA). LOT 080023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MARCH-2008. EXPIRATION DATE: 2013-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. PRELIMINARY INSPECTION PERFORMED BY R&D PROJECT MANAGER ON THE CUP: THE PHOTO AND RECEIVED INFORMATION DOES NOT PROVIDE ANY PARTICULAR ELEMENT TO BE USED TO DETERMINE THE ROOT CAUSE OF THE EVENT, AS NO PARTICULAR SIGNS ARE VISIBLE IN THE PHOTO.

    Description of Event or Problem · 0

    AT 13 YEARS AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED DUE TO STEM AND CUP MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775688 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.022 081892 07630030802034

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention