BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE2

    MDR report key: 7718470 · Received July 25, 2018

    Report

    Report Number
    3005180920-2018-00544
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 25, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804670
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JULY 2018: LOT 133015:30 ITEMS MANUFACTURED AND RELEASED ON 02 SEPTEMBER 2013. EXPIRATION DATE: 2018-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON JUL 12, 2018: PARTIAL HIP REVISION SURGERY (STEM, HEAD AND LINER) OCCURRED 3 YEARS AND 6 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES AROUND THE STEM SUGGESTING MOBILIZATION. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 3 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGEON DETERMINED THAT THE STEM HAD POTTED. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561770 AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE2 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.242 133015 07630030804670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention