BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 5

    MDR report key: 11001861 · Received December 14, 2020

    Report

    Report Number
    3005180920-2020-00898
    Event Type
    Injury
    Date Received
    December 14, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 14, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802065
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2020: LOT 1902332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A REVISION THR (14 DAYS AFTER PRIMARY SURGERY) DUE TO A PROXIMAL FEMORAL FRACTURE OCCURRING POST OPERATIVELY. THE PRIMARY STEM WAS REMOVED, THE FRACTURE WAS CABLED & A QUADRA C STEM WAS IMPLANTED USING PALACOS CEMENT. THE CUP AND LINER WERE NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469440 STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 5 UNCEMENTED HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.025 1902332 07630030802065

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention