BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 1 STD

    MDR report key: 6812710 · Received August 23, 2017

    Report

    Report Number
    3005180920-2017-00462
    Event Type
    Injury
    Date Received
    August 23, 2017
    Report Date
    August 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 18 AUGUST 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PARTIAL REVISION (FEMORAL STEM) IN CEMENTLESS DOUBLE MOBILITY THA ON A YOUNG LADY AFTER TWO YEARS. THE STEM APPEARS TO BE LOOSE ON THE SUPPLIED RADIOGRAPHS. SOME SCLEROTIC LINES ARE ALSO VISIBLE AROUND THE CUP, WHICH HAS NOT BEEN REVISED THOUGH. THE STEM APPEARS TO HAVE A RATHER SIGNIFICANT ANTEVERSION BUT THIS CANNOT BE ASSUMED TO BE THE CAUSE FOR LOOSENING. ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING THA AND VERY OFTEN, LIKE IN THIS CASE, THE MAIN CAUSE REMAINS UNKNOWN. BATCH REVIEWS PERFORMED ON 21 AUGUST 2017. LOT 150841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MAY 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5, CODE 01.29.203, LOT. 148656 (K112115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MARCH 2015. EXPIRATION DATE: 2020-02-29. 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. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 48/28, CODE 01.26.2848MHC, LOT. 151096 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 JULY 2015. EXPIRATION DATE: 2020-05-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF LAXITY. THE CAUSE OF LAXITY IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS WILL NOT BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593068 AMISTEM H, HA COATED STEM SIZE 1 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 150841 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention