BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1

    MDR report key: 10976726 · Received December 9, 2020

    Report

    Report Number
    3005180920-2020-00876
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    November 10, 2020
    Report Date
    September 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802027
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 141056: 60 ITEMS MANUFACTURED AND RELEASED ON 17-APR-2014. EXPIRATION DATE: 31-MAR-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO PAIN AND STEM LOOSENING AFTER 5 YEARS FROM THE PRIMARY SURGERY. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014 AND THE ISSUE WAS DISCOVERED DURING A CLINICAL VISIT FOLLOW-UP ON THE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444401 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.021 141056 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention