BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 7605413 · Received June 15, 2018

    Report

    Report Number
    3005180920-2018-00433
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    June 15, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON 07 JUNE 2018. HIP REVISION SURGERY IN A (B)(6) WOMAN. NO INFORMATION ON DATE OF PRIMARY SURGERY IS AVAILABLE. RADIOGRAPHIC IMAGE PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1 AND 7 AND REDUCED BONE DENSITY IN THE GREATER TROCHANTER REGION. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT FOLLOWING CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 15 JUNE 2018. FROM IMAGES AND X-RAY PRELIMINARY INVESTIGATION, FEMORAL STEM SHOWS SIGNS OF EXTRACTION PROCESS ON THE TAPER AND PROXIMAL NECK AREA. HYDROXYAPATITE LAYER HAS BEEN COMPLETELY ABSORBED DURING IN-SITU TIME. BATCH REVIEW PERFORMED ON 15 JUNE 2018. LOT 132630: 70 ITEMS MANUFACTURED AND RELEASED ON 02 SEPTEMBER 2013. EXPIRATION DATE: 31 JULY 2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 69 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    WE WERE INFORMED ON (B)(6) 2018 THAT A REVISION SURGERY WILL BE DONE ON (B)(6) 2018 DUE TO STEM LOOSENING. ON (B)(6) 2018 WE WERE INFORMED THAT THE REVISION SURGERY WAS PERFORMED (RIGHT SIDE) WAS DONE ON (B)(6) 2018. PRIMARY SURGERY PERFORMED IN 2013 (EXACT DATE NOT AVAILABLE AT THE MOMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449462 AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 132630 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention