BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1

    MDR report key: 14250187 · Received April 29, 2022

    Report

    Report Number
    3005180920-2022-00314
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 4, 2022
    Report Date
    July 14, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802027
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 124026: (B)(6) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2017-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    ON THE 05TH OF JULY 2022 WE HAVE RECEIVED THE STEM INVOLVED IN THE EVENT AND THE LINER AND THE HEAD EVEN IF ARE ASSOCIATED COMPONENT. VISUAL INSPECTIION PERFORMED BY R&D PROJECT MANAGER: DURING THE VISUAL INSPECTION IT HAS BEEN NOTICED THAT PART OF THE PROXIMAL ASPECT OF THE STEM IS COVERED WITH HA COATING MEANING THAT THE STEM WAS NOT COMPLETELY OSSEOINTEGRATED WITH THE PATIENT BONE. SOME SIGNS AND SCRATCHES ARE PRESENT ON THE NECK SURFACE OF THE STEM AND ON THE PE LINER PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF UNCORRECT STEM OSSEOINTEGRATION.

    Description of Event or Problem · 0

    REVISION SURGERY FOLLOWING STEM LOOSENING, NO INFECTION HAS BEEN DETECTED. THE DEVICE WAS IMPLANTED IN 2013, THE EXACT PRIMARY SURGERY DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109510 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.021 124026 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention