BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-P QUADRA-P LAT STEM SIZE 7

    MDR report key: 18266171 · Received December 5, 2023

    Report

    Report Number
    3005180920-2023-00979
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    August 22, 2023
    Report Date
    January 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720595
    PMA / PMN Number
    K181254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT ON (B)(6) 2024 ALMOST 1 YEAR AFTER A PRIMARY THA, USING QUADRA-P IMPLANT, STEM RADIOLUCENCIES WERE NOTICED BY THE SURGEON DURING A POST-OP X-RAY CHECK. NO CLINICAL INFORMATION ABOUT THE PATIENT WAS REPORTED AND NO REVISION SURGERY IS PLANNED. FROM THE AVAILABLE X-RAYS IMAGES, RADIOLUCENCY LINES ARE APPRECIABLE AROUND THE PROXIMAL FEMUR, IN BOTH THE AP AND LATERAL VIEWS, AND ALSO A SLIGHTLY SHORTENED LEG (OR PERHAPS SUBSIDENCE OF THE STEM SECONDARY TO LOOSENING). AS THE IMMEDIATE POST-OP IMAGES ARE UNAVAILABLE, NO COMMENT CAN BE MADE ON THE DEVELOPMENT OF THE RADIOLUCENT LINES. THIS SHORT TERM OUTCOME IS VERY RARE AND SURPRISING AND WE ARE UNABLE TO MAKE A REASONABLE FORECAST OF THE POSSIBLE EVOLUTION.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 NOVEMBER 2023. LOT 2000333: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2020. EXPIRATION DATE: 2025-MAY-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE SURGEON NOTED RADIOLUCENT LINES ON RADIOGRAPHS 1 YEAR AFTER SURGERY AND DIAGNOSED MILD STEM LOOSENING ON THE LEFT HIP IN ZONE 1/7/8. THE PATIENT DOES NOT COMPLAIN OF ANY PAIN OR DISCOMFORT. REVISION SURGERY IS NOT PLANNED. THE PATIENT WILL BE MONITORED. NOTE: PATIENT IS BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204921 STEM: QUADRA-P QUADRA-P LAT STEM SIZE 7 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2000333 07630040720595

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention