BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 8548595 · Received April 25, 2019

    Report

    Report Number
    3005180920-2019-00312
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    March 28, 2019
    Report Date
    April 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    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 23 APRIL 2019: LOT 142339: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2014. EXPIRATION DATE: 2019-05-31. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: HIP REVISION SURGERY OCCURRED 4, 5 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES AROUND THE STEM AND SIGNS OF STRESS SHIELDING.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 4 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY A SUBSIDED STEM. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345377 STEM: AMISTEM H HA COATED STD STEM SIZE 1 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 142339 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention