BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 7

    MDR report key: 8649828 · Received May 29, 2019

    Report

    Report Number
    3005180920-2019-00425
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY OCCURRED 6 YEARS AFTER CEMENTLESS TOTAL HIP ARTHOPLASTY IN A HEAVY (B)(6) MAN AT TIME OF IMPLANTATION. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1 AND 7 SUGGESTING IMPLANT MOBILIZATION. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED MID TERM ADVERSE EVENT AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 27 MAY 2019: LOT 110840: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2011. EXPIRATION DATE: 2016-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANOTHER SIMILAR REPORTED EVENT [MDR2019-00204]. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THA LAYER COMPLETELY ABSORBED. DEEP SCRATCH ON ONE SIDE, PROBABLY DUE TO IMPLANT REMOVAL. IT IS NOT POSSIBLE TO DETERMINE THE FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    ABOUT 6 YEARS AFTER PRIMARY REVISION SURGERY FOR STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE STEM AND THE CERAMIC HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442222 STEM: AMISTEM H HA COATED STD STEM SIZE 7 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 110840 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention