BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3

    MDR report key: 15092008 · Received July 25, 2022

    Report

    Report Number
    3005180920-2022-00565
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 4, 2022
    Report Date
    July 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802157
    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 08-JUL-2022: LOT 170188: 60 ITEMS MANUFACTURED AND RELEASED ON 04-AUG-2017. EXPIRATION DATE: 2022-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 58 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: REVISION 5 YEARS AFTER THA IN A 70 YEAR OLD PATIENT DUE TO ASEPTIC LOOSENING. DURING THIS TIME A PARTIAL REVISION OF THE ANCETABULAR IMPLANT WAS PERFORMED DUE TO RECURRING LUXATION, POSSIBLY INFLUENCED BY THE VARUS POSITION OF THE STEM. THERE ARE NO POST OPERATIVE RADIOGRAPHS THAT LET US EVALUATE IF THIS POSITION WAS THE RESULT OF THE INDEX OPERATION (WHICH IS MORE LIKELY BECAUSE THE STEM LOOKS UNDERSIZED) OR IF IT HAPPENED LATER. NOW THE STEM HAS BEEN REVISED. ONLY THE OPERATED SIDE IS VISIBLE IN THE IMAGE, THEREFORE IT IS NOT POSSIBLE TO COMPARE THE STEM POSITION WITH THE CONTROLATERAL SIDE.RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONE 1 AND SIGNS OF STRESS-SHIELDING.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AFTER ABOUT 5 YEARS DUE TO STEM MOBILIZATION. THE PATIENT ALREADY UNDERWENT REVISION SURGERY DUE TO HIP LUXATION IN 2018 WHERE A DOUBLE MOBILITY SYSTEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533000 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.033 170188 07630030802157

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention