BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3

    MDR report key: 11453191 · Received March 10, 2021

    Report

    Report Number
    3005180920-2021-00199
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    January 28, 2021
    Report Date
    May 11, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802157
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07-MAY-2021 BATCH REVIEW WAS CORRECTED, HERE BELOW THE UPDATED VERSION. BATCH REVIEW PERFORMED ON 07 MAY 2021: LOT :152230: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JULY-2015. EXPIRATION DATE: 2020-06-30. 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.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2021: LOT 152230: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JULY-2015. EXPIRATION DATE: 2020-06-30. 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

    REVISION SURGERY 4 YEARS AND 10 MONTHS AFTER PRIMARY, FOR STEM LOOSENING. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353900 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.033 152230 07630030802157

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention