BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8743233 · Received June 28, 2019

    Report

    Report Number
    3005180920-2019-00519
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802614
    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 25 JUNE 2019: LOT 162966: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JUNE 2016. EXPIRATION DATE: 2021-05-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: HIP REVISION PERFORMED 2 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN AN OVERWEIGHT WOMAN. RADIOGRAPHIC IMAGES PROVIDED SHOW STEM SUBSIDENCE AND SHORTENED LEG. ACCORDING TO THE REPORT THE PATIENT WAS COMPLAINING ABOUT PAIN SINCE 6 MONTHS AFTER SURGERY. NO PREOPERATIVE OR IMMEDIATE POSTOPERATIVE X-RAY IS AVAILABLE. IMPLANT SUBSIDENCE MAY BE DUE TO SLIGHTLY UNDERSIZED IMPLANT BUT ALSO PATIENT WEIGHT AND DEVELOPING BONE QUALITY ALTERATIONS MAY FACILITATE THE OCCURRENCE OF THIS EVENT. THE REASON OF THIS EVENT CANNOT BE DETERMINED. VISUAL INSPECTION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: FEMORAL STEM: FEW SCRATCHES AND OPAQUE REGIONS ON THE NECK. STEM SHOWS BONE RESIDUALS. ACETABULAR SHELL WITH SIGNS OF REMOVAL; THE PE LINER SHOWS REMOVAL SIGNS AS WELL. NOTHING TO HIGHLIGHT REGARDING FEMORAL HEAD. IT IS NOT POSSIBLE TO DETERMINE FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER ABOUT 2 YEARS FROM THE PRIMARY DUE TO HIP STEM SINKING. THE SURGERY WAS COMPLETED SUCCESSFULLY, ALL DEVICES REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538806 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK UNCEMENTED HIP STEM JDI MEDACTA INTERNATIONAL SA 162966 07630030802614

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention