BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 4

    MDR report key: 15860278 · Received November 24, 2022

    Report

    Report Number
    3005180920-2022-00870
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    November 16, 2022
    Report Date
    February 8, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804205
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TO BE RECEIVED AND ANALYZED. X-RAYS ANALYSIS TO BE PERFORMED. ADDITIONAL INFORMATION AND RESULTS OF THE ANALYSIS COULD BE AVAILABLE IN THIS CASE FOLLOW UP 1.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 9 JANUARY 2023: LOT 112384: 10 ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2011. EXPIRATION DATE: 2016-JUL-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT REVISION APPROXIMATELY 6 YEARS AFTER INDEX SURGERY IN A MALE PATIENT DUE TO ASEPTIC LOOSENING. FROM THE IMAGES, SIGNS OF STRESS SHIELDING AND RADIOGRAPHIC LOOSENING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND ITS CAUSES ARE OFTEN UNKNOWN. THE REASON FOR THIS FAILURE CANNOT BE DETERMINED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER DURING THE ANALYSIS IT WAS EVALUATED THAT ALMOST THE PROXIMAL HALF OF THE STEM BODY IS STILL COVERED WITH HA COATING. THIS IN UNEXPECTED CONSIDERING THAT THE STEM WAS IMPLANTED SIX YEARS AGO. SOME SIGNS AND SCRATCHES ARE PRESENT ON THE NECK SURFACE, PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED LOOSENING.

    Description of Event or Problem · 0

    AMISTEM IMPLANTED APPROXIMATELY 6 YEARS AGO. REVISION SURGERY PERFORMED DUE TO ASEPTIC LOOSENING. WAITING FOR INFO REGARDING REVISION.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED APPROXIMATELY 10 YEARS AFTER THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917902 STEM: AMISTEM H HA COATED LAT STEM SIZE 4 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.144 112384 07630030804205

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention