BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18266173 · Received December 5, 2023

    Report

    Report Number
    3005180920-2023-00980
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    August 15, 2023
    Report Date
    January 26, 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 MEDICAL AFFAIRS DEPARTMENT ON 02-JAN-2024: ALMOST FOUR MONTH 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, RADIOLUCENCIES LINES ARE APPRETIABLE 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 NOT AVAILABLE, NO COMMENT CAN BE MADE AS TO 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 INFORMATION OF THIS FU: CLINICAL EVALUATION.

    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 3,5 MONTHS AFTER SURGERY AND DIAGNOSED MILD STEM LOOSENING ON THE RIGHT HIP IN THE 1/7/8/14 AREA. 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
    2204923 STEM: QUADRA-P QUADRA-P LAT STEM SIZE 7 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2000333 07630040720595

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention