BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 4 STD

    MDR report key: 6529616 · Received April 28, 2017

    Report

    Report Number
    3005180920-2017-00223
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    March 30, 2017
    Report Date
    April 28, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 06 APRIL 2017 AND INCLUDES: THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY ON (B)(4) 2017. BATCH REVIEW PERFORMED ON 24 APRIL 2017. LOT 102801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2010. EXPIRATION DATE: 2015-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 26 APRIL 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE IMAGES AND COMMENTED AS FOLLOWS: THE IMAGES WERE ANALYZED. FROM THE PHOTO IT IS VISIBLE THAT ALL THE HA COATING WAS ABSORBED, WHILE SOME BLOOD WAS STILL PRESENT IN THE MACROSTRUCTURES. THE NECK HAD SOME SCRATCHES PROBABLY OCCURRED DURING THE EXTRACTION. FROM THE RECEIVED IMAGE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. ON 28 APRIL 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: STEM REVISION 6 YEARS AFTER PRIMARY CEMENTLESS THA. THE PATIENT WAS COMPLAINING ABOUT THIGH PAIN. RADIOGRAPHS PROVIDED SHOW SIGN OF STRESS SHIELDING. THIS EVENT IS A POSSIBLE LONG-TERM, LITERATURE DESCRIBED, ADVERSE EVENT FOLLOWING TOTAL HIP ARTHROPLASTY. THE REASON CANNOT BE DETERMINED. NOT AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY 6 YEARS AND 3 MONTHS AFTER PRIMARY DUE TO THIGH PAIN: STRESS SHIELDING VISIBLE ON X-RAY. REVISION PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312021 AMISTEM H, HA COATED STEM SIZE 4 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 102801

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention