BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS LAT STEM SIZE 4

    MDR report key: 8421077 · Received March 14, 2019

    Report

    Report Number
    3005180920-2019-00160
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    January 10, 2019
    Report Date
    April 11, 2019
    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 · 0

    ON MARCH 15, 2019 WE RECEIVED X-RAYS OF THE PATIENT AND THEY WERE EVALUATED AS FOLLOWS BY THE MEDICAL AFFAIRS MANAGER: HIP REVISION SURGERY OCCURRED ABOUT 6 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN AN ELDERLY WOMAN (82 YEAR OLD). RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES AROUND THE STEM AND SIGNS OF STRESS SHIELDING SUGGESTING IMPLANT MOBILIZATION. THE STEM LOOKS SLIGHTLY UNDERSIZED BUT THE REASON OF THIS CHOICE CANNOT BE ASSESSED ON THE BASIS OF A SINGLE PRE-REVISION ANTEROPOSTERIOR RADIOGRAPHIC PROJECTION. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS THA AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 MARCH 2019: LOT 123766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT HAD STARTED TO COMPLAIN ABOUT HIP PAIN ON (B)(6) 2017, 4 YEARS AFTER PRIMARY. THE X-RAY HAD SHOWED A SHAFT LOOSENING. SINCE THE SYMPTOMS WERE NOT THAT STRONG YET AND THERE WERE MUSCULAR PROBLEMS, THEY INITIALLY AGREED ON A PHYSIOTHERAPY WITH THE INSTRUCTION THAT IF THE PAIN INTENSIFIED A STEM CHANGE WOULD HAVE TO BE MADE. 1 YEAR AND 8 MONTHS LATER, THAT MEANS 5 YEARS AND 8 MONTHS AFTER THE PRIMARY CASE, THE PATIENT WAS REVISED, WITH EXCLUSION OF INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY REPLACING THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214938 QUADRA-H CEMENTLESS LAT STEM SIZE 4 HIP STEM CEMENTLESS JDI MEDACTA INTERNATIONAL SA 123766 07630030802164

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention