BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 8208003 · Received January 2, 2019

    Report

    Report Number
    3005180920-2018-01049
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 102763: 60 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2010. EXPIRATION DATE: 2015-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) TEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON (B)(6) 2019 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: HIP REVISION SURGERY WAS REQUIRED 8 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) PATIENT. IN THE RADIOGRAPHIC IMAGE POVIDED, THE STEM LOOKS MOBILIZED AND THE LEG IS SHORTER THAN THE CONTRALATERAL. NO CASE HISTORY WAS PROVIDED AND THEREFORE NO FURTHER COMMENT OR CONCLUSION CAN BE MADE. WE DO NOT KNOW HOW THE SYSTEM WORKED FOR THE FORMER 8 YEARS AND WHEN AND HOW THE PROBLEMS ONSET. THERE IS NO INDICATION THAT A DEFECTIVE DEVICE CAUSED THE PROBLEM.

    Description of Event or Problem · 1

    REVISION OF AN AMISTEM-H IS PLANNED FOR (B)(6) 2018 DUE TO INSUFFICIENT OSSEOINTEGRATION IN THE PROXIMAL REGION OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618 AMISTEM H FEMORAL STEM FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 102763 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention