BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H HA COATED STD STEM SIZE 3

    MDR report key: 7150722 · Received December 28, 2017

    Report

    Report Number
    3005180920-2017-00791
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 28, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 22 DECEMEBR 2017: PARTIAL HIP REVISION SURGERY (STEM AND HEAD) OCCURRED 3 YEARS AFTER PRIMARY TOTAL HIP REPLACEMENT. 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. IN THIS CASE, THE REASON OF FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 28 DECEMBER 2017 LOT 143131: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JULY 2014. EXPIRATION DATE: 2019-06-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 3 YEARS AFTER PRIMARY DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931009 AMISTEM-H HA COATED STD STEM SIZE 3 CEMENTLSS HIP STEM LZO MEDACTA INTERNATIONAL SA 143131 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention