BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 5

    MDR report key: 8064115 · Received November 13, 2018

    Report

    Report Number
    3005180920-2018-00885
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 24, 2018
    Report Date
    November 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804212
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY (STEM AND HEAD) OCCURRED 3 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1, 2, 6 AND 7 AND SIGNS OF STRESS SHIELDING SUGGESTING STEM MOBILIZATION. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS HIP REPLACEMENT AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 12 NOVEMBER 2018. LOT 152132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 AUGUST 2015. EXPIRATION DATE: 2020-07-14. 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

    ON OCT 15, 2018 WE WERE INFORMED THAT 2 YEARS AND 10 MONTHS AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF PAIN. ON (B)(6) 2108 THE SURGEON REVISED THE HIP FOR A STEM POTTING (DISTAL FIXATION + PROXIMAL RADIOLUCENCY). STEM, HEAD AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904776 STEM: AMISTEM H HA COATED LAT STEM SIZE 5 HA HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 152132 07630030804212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention