BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0

    MDR report key: 17486503 · Received August 9, 2023

    Report

    Report Number
    3005180920-2023-00627
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 9, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802010
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07-AUG-2023: LOT 162208: (B)(4). ADDITIONAL DEVICE INVOLVED: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 2007636: (B)(4).

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 4 MONTHS AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF IMPLANT SUBSIDENCE WHICH CAUSED LEG LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099570 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0 HIP UNCEMENTED STEM JDI MEDACTA INTERNATIONAL SA 162208 07630030802010

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention