BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM HA COATED STD STEM SIZE 1

    MDR report key: 9128851 · Received September 27, 2019

    Report

    Report Number
    3005180920-2019-00817
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    August 29, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RECEIVED ON THE (B)(6) 2019 AND ANALYZED ON THE (B)(6) 2019 BY MEDACTA R&D PROJECT MANAGER. THE DEVICES WERE REPORTED AS NOT AVAILABLE IN THE COMPLAINT. VISUAL INSPECTION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: NO RESIDUAL HA LAYER ON THE STEM, FEMORAL NECK SEEMS SCRATCHED DUE TO HEAD REMOVAL OR UNKNOWN REASON; SIGNS OF REMOVAL ATTEMPT ON THE CERAMIC HEAD.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 24TH OCTOBER 2019: 6 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM IS FOUND LOOSE AND REVISED. WE HAVE ONLY ONE PRE-REVISION XRAY THAT SHOWS A STEM OF RATHER SMALL DIMENSION IN A BONE THAT LOST STRENGTH, BUT WE DO NOT HAVE THE RADIOPHIC HISTORY TO HELP US UNDERSTAND THE EVOLUTION FROM THE POSTOPERATIVE SITUATION TO THE LOOSENING. WE ARE UNABLE TO SUGGEST A VALID REASON FOR THIS EVENT, WITH THE INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    DEVICE RECEIVED ON THE (B)(6) 2019 AND ANALYZED ON THE (B)(6) 2019 BY MEDACTA R&D PROJECT MANAGER. THE DEVICES WERE REPORTED AS NOT AVAILABLE IN THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 SEPTEMBER 2019: LOT 131150: 60 ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2013. EXPIRATION DATE: 2018-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    MICRO MOVEMENTS OF THE PROSTHESIS, ALMOST 6 YEARS AFTER PRIMARY, WHICH RESULTED IN THIGH PAIN AND DECREASED PERIMETER OF WALKING. THE STEM HAS BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925676 STEM: AMISTEM HA COATED STD STEM SIZE 1 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 131150 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention