BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 7251038 · Received February 8, 2018

    Report

    Report Number
    3005180920-2018-00022
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    January 9, 2018
    Report Date
    February 8, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 FEBRUARY 2018, LOT 172601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 NOVEMBER 2017. EXPIRATION DATE: 2022-10-23 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. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 08 FEBRUARY 2018: WITH THIS INVESTIGATION WE TAKE IN CONSIDERATION BOTH THE PRELIMINARY INSPECTION AND THE VISUAL INSPECTION. THE ONLY RECEIVED PHOTO AND PIECE WAS THE CERAMIC BALL HEAD. THE RETURNED PIECE WAS ANALYZED: THE ONLY SIGNS NOTICED WERE IN THE INNER TAPER, DUE TO THE CONNECTION WITH THE STEM, AND SOME LITTLE SIGNS ON THE EXTERNAL SURFACE, MOST PROBABLY DUE TO THE EXTRACTION. DUE TO THE PARTIAL RECEIVED PIECE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IMMEDIATELY AFTER THE SURGERY, THE SURGEON CONFIRMED THAT THE FEMORAL STEM WAS SUBSIDED IN THE XRAY. BONE FRACTURE WAS NOT CONFIRMED. IT LOOKED THE FEMORAL STEM FIXATION WAS GOOD. THEREFORE, THE SURGEON DECIDED TO REPLACE WITH FEMORAL HEAD ONLY. REVISION SURGERY WAS PERFORMED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99262 AMISTEM H HA COATED STD STEM SIZE 1 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 172601 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention