BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 7

    MDR report key: 9488566 · Received December 18, 2019

    Report

    Report Number
    3005180920-2019-01081
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    November 27, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 NOVEMBER 2019. LOT 124059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-DEC-2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY PERFORMED 3 YEARS AND 8 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, GENERAL HEALTH STATUS AND COMORBIDITIES IS AVAILABLE. RADIOGRAPHIC IMAGE PROVIDED DOESN'T ALLOW A PROPER CLINICAL EVALUATION DUE TO POOR QUALITY. ON THE BASIS OF INFORMATION RECEIVED, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 3 YEARS AND 8 MONTHS AFTER THE PRIMARY DUE TO A POTTED STEM. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283153 STEM: AMISTEM H HA COATED STD STEM SIZE 7 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 124059 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention