BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 7718468 · Received July 25, 2018

    Report

    Report Number
    3005180920-2018-00534
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    June 25, 2018
    Report Date
    July 25, 2018
    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 · 1

    BATCH REVIEW PERFORMED ON 24 JULY 2018. LOT 133082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 12 JULY 2018. TOTAL HIP REVISION SURGERY OCCURRED 4 YEARS AFTER IMPLANTATION OF A CEMENTLESS THA IN A (B)(6) YEAR OLD MAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF SIGNS OF STRESS-SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. ON THE BASIS OF INFORMATION RECEIVED, THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ABOUT 4 YEARS AFTER SURGERY, THE SURGEON REVISED THE PATIENT FOR STEM LOOSENING AND A STRONG INFECTION SUSPICION. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON 12 JULY 2018 WE WERE INFORMED THAT NO INFECTION WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561768 AMISTEM H HA COATED LAT STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 133082 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention