BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 15147043 · Received August 2, 2022

    Report

    Report Number
    3005180920-2022-00597
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    July 13, 2022
    Report Date
    August 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 JULY 2022 LOT 140749: LOT 140749: (B)(4). EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). CLINICAL EVALUATION PERFORMED ON 27-JUL-2022 LOT. 140749: REVISION 7 YEARS AND 5 MONTHS AFTER THE CEMENTLESS THA IN A FEMALE PATIENT DUE TO STEM LOOSENING. THE PATIENT REPORTED PAIN. THE RADIOGRAPHIC IMAGE SHOWS THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1 AND 7 AND SIGNS OF STRESS SHIELDING ARE VISIBLE. THE CUP IS A DM CUP THEREFORE THE LINER, THE HEAD AND THE STEM WERE REVISED WHILE, THE METAL CUP WAS NOT. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    AT 7 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032618 STEM: AMISTEM H HA COATED STD STEM SIZE 2 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 140749 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention