BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 14486028 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00401
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2022: LOT 160757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2016. EXPIRATION DATE: 2021-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS SPECIALIST: HIP REVISION SURGERY PERFORMED 5 YEARS AFTER TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES IN ZONES 1 AND 7. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. 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. HIP R&D PROJECT MANAGER PICTURES ANALYSIS: LOOKING AT THE IMAGE OF THE STEM ATTACHED TO THE COMPLAINT IT IS VISIBLE THAT THE EXPLANTED STEM IS COVERED WITH PATIENT BLOOD. IT SEEMS THAT NO SIGNS OF HA COATING ARE PRESENT, EVEN IF IT IS NOT EASY TO EVALUATE. ADDITIONAL INFO WILL BE ADDED DURING THE VISUAL INSPECTION ANALYSIS IF THE STEM WILL BE AVAILABLE. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF STEM LOOSENING.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE ANALYSIS IT IS EVALUATED THAT ALMOST PROXIMAL HALF OF THE STEM IS STILL COVERED WITH HA COATING. THIS IS UNEXPECTED AFTER 5 YEARS OF IMPLANTATION, MEANING THAT THE STEM WAS NOT CORRECTLY OSSEOINTEGRATED WITH THE PATIENT BONE. SOME SIGNS AND SCRATCHES ARE PRESENT ON THE NECK PART PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF INCORRECT OSSEOINTEGRATION AND ASEPTING LOOSENING.

    Description of Event or Problem · 0

    AT 5 YEARS 1 MONTH AFTER THE PRIMARY, REVISION SURGERY FOLLOWING THE ASEPTIC LOOSENING OF THE STEM DUE TO INSUFFICIENT OSSEOINTEGRATION. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517659 AMISTEM H HA COATED LAT STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.143 160757 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention