BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 14019162 · Received April 6, 2022

    Report

    Report Number
    3005180920-2022-00238
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 9, 2022
    Report Date
    April 6, 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

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. PARTIAL REVISION PERFORMED 7 YEARS AFTER PRIMARY TOTAL HIP ARTHROPLASTY IN A MALE PATIENT WITH A VERY NARROW FEMORAL CANAL AND GOOD CORTICES. FROM THE RADIOGRAPHIC IMAGE, A HETEROTOPIC OSSIFICATION (HO) IS VISIBLE ON THE GREAT THROCANTER, BUT ITS RELATIONSHIP WITH THE ADVERSE EVENT IS DOUBTFUL. THERE ARE SIGNS OF A PREVIOUS DIAPHYSEAL FEMORAL FRACTURE (DATE OF OCCURRENCE UNKNOWN), WHICH MAY HAVE CHANGED OR INFLUENCED THE DIAPHYSEAL MECHANICS AND THEREFORE CONTRIBUTED TO THE POTTING OF THE STEM. THE QUALITY OF THE IMAGES SUPPLIED DOES NOT ALLOW FURTHER CONCLUSIONS TO BE DRAWN. BATCH REVIEW PERFORMED ON 10 MARCH 2022. LOT 146952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JAN-2015. EXPIRATION DATE: 2019-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT SINCE 1-1-2018.

    Description of Event or Problem · 0

    AT 7 YEARS AND 1 MONTHS POST PRIMARY, THE SURGEON REVISED THE PATIENT FOR STEM LOOSENING. STEM AND HEAD REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339483 STEM: AMISTEM H HA COATED STD STEM SIZE 2 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.132 146952 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention