BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 7357662 · Received March 21, 2018

    Report

    Report Number
    3005180920-2018-00165
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 MARCH 2018; LOT 173491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2017. EXPIRATION DATE: 2022-09-28. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 02 MARCH 2018: POSTOPERATIVE FEMORAL FRACTURE OCCURRED ONE MONTH AFTER PRIMARY IMPLANTATION IN A 69 YEAR OLD WOMAN. THE INITIAL STEM POSITION AND DIMENSION OF THE STEM CANNOT BE ASSESSED AS NO IMMEDIATE POSTOPERATIVE X-RAY WAS PROVIDED. THE REASON OF FRACTURE IS UNKNOWN: INTRAOPERATIVE BONE WEAKENING DUE TO NORMAL FEMORAL PREPARATION COULD BE ONE REASON BUT ALSO OTHER FACTORS MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    PATIENT REPORTED THIGH PAIN 1 MONTHS AFTER PRIMARY AND X-RAY REVEALED A FEMORAL FRACTURE AROUND THE STEM. PRIMARY SURGERY WENT FINE WITH NO SUSPECTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200300 AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 173491 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention