BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 4

    MDR report key: 11053943 · Received December 22, 2020

    Report

    Report Number
    3005180920-2020-00946
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    September 16, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802164
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 DECEMBER 2020: LOT 152984: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2015. EXPIRATION DATE: 2020-09-22. 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 SINCE 2016.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON THE (B)(6) 2020, 4 AND A HALF YEAR AFTER PRIMARY, DUE TO STEM LOOSENING. EXACT PRIMARY SURGERY DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518004 STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 4 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.034 152984 07630030802164

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention