BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS MOBILE LEG POSITIONER 2.0 FRAME

    MDR report key: 7984644 · Received October 19, 2018

    Report

    Report Number
    3005180920-2018-00801
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 OCTOBER 2018. LOT 1656236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8 MARCH 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. ADDITIONAL ITEM INVOLVED IN THE EVENT: STEM: AMIS-K 01.20.003 AMIS-K SIZE 2S1 STANDARD (NOT REGISTERED IN US), LOT 181278: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 APRIL 2017. EXPIRATION DATE:2023-04-12. 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. AMIS 01.15.10.0315 AMIS SHOE LOT 1754696: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 FEBRUARY 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FRACTURE OF A FEMORAL CONDYLE WAS DETECTED AFTER PRIMARY THA WITH CEMENTED FEMORAL STEM. THE RELATIONSHIP BETWEEN THE FRACTURE AND THE HIP OPERATION IS UNKNOWN AND QUITE UNLIKELY. WE SEE NO POSSIBILITY THAT THIS MAY HAVE BEEN CAUSED BY A FAULTY DEVICE.

    Description of Event or Problem · 1

    FEMORAL CONDYLE BONE FRACTURE DISCOVERED THROUGH THE X-RAYS AFTER HIP SURGERY. IT IS UNKNOWN WHEN THE FRACTURE OCCURRED BECAUSE NO X-RAYS AROUND THE KNEE WERE TAKEN BEFORE THE SURGERY. THE PATIENT WILL BE FOLLOWED-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823726 AMIS MOBILE LEG POSITIONER 2.0 FRAME SURGICAL INSTRUMENT FOR HIP SURGERIES LHX MEDACTA INTERNATIONAL SA 1656236

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other