BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H COATED STD STEM SIZE 1

    MDR report key: 9493946 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01077
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 26, 2019
    Report Date
    March 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN AND SWELLING, AND THE FRACTURE DISCOVERED IN X-RAY 15 DAYS AFTER PRIMARY. THE PATIENT STOPS THE REHABILITATION AND THE SURGEON CONTINUES TO FOLLOW UP. THE SURGEON EXPRESSED AN OPINION THAT THE SELECTED STEM SIZE MIGHT BE LARGE, AND THE STRESS WAS CONCENTRATED ON THE FRACTURED PART BECAUSE THE STEM WAS INSERTED SLIGHTLY LATERAL. THIS WAS THE 1ST AMIS SURGERY FOR THE SURGEON. NO REVISION SURGERY IS PLANNED. NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 DECEMBER 2019: LOT 1903333: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2019. EXPIRATION DATE: 2024-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FEMORAL FRACTURE. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT HAD A PAIN AND A SWELLING, AND THE FRACTURE DISCOVERED IN X-RAY 15 DAYS AFTER PRIMARY. THE PATIENT STOPS THE REHABILITATION AND THE SURGEON CONTINUES TO FOLLOW UP. THE SURGEON EXPRESSED AN OPINION THAT THE SELECTED STEM SIZE MIGHT BE LARGE, AND THE STRESS WAS CONCENTRATED ON THE FRACTURED PART BECAUSE THE STEM WAS INSERTED SLIGHTLY LATERAL. THIS WAS THE 1ST AMIS SURGERY FOR THE SURGEON. NO REVISION SURGERY IS PLANNED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287156 STEM: AMISTEM H COATED STD STEM SIZE 1 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 1903333 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention