BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H AMISTEM-H LAT SIZE 3

    MDR report key: 8099785 · Received November 23, 2018

    Report

    Report Number
    3005180920-2018-00943
    Event Type
    Injury
    Date Received
    November 23, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 NOVEMBER 2018: LOT 113805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2011. EXPIRATION DATE: 2016-10-31. 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. VISUAL INSPECTION PERFORMED ON NOVEMBER 21, 2018 BY R&D PRODUCT MANAGER: VISUAL INSPECTION HIGHLIGHTS HYDROXYAPATITE LAYER TOTALLY ABSORBED. FEW SIGNS OF FEMORAL EXTRACTION ARE VISIBLE ON NECK AND TAPER. IT IS NOT POSSIBLE TO DETERMINE A DEVICE RELATED ROOT CAUSE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON "NOVEMBE" 22, 2018: HIP REVISION SURGERY OCCURRED 6,5 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) MAN. IN THE POST-IMPLANTATION RADIOGRAPHIC IMAGE, THE STEM LOOKS SLIGHTLY UNDERSIZED AND IN VARUS POSITION. THE REASON OF THIS CHOICE CANNOT BE DETERMINED: PATIENT ANATOMY MAY BE ONE REASON BUT NO CONCLUSION CAN BE DRAWN ON THE BASIS OF THE INFORMATION AND IMAGES PROVIDED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 6 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY, DUE TO AMISTEM H LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938744 AMISTEM H AMISTEM-H LAT SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 113805 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention