BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM SIZE 2

    MDR report key: 7578033 · Received June 7, 2018

    Report

    Report Number
    3005180920-2018-00400
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    May 9, 2018
    Report Date
    July 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED ON 08 JUNE 2018 BY MEDICAL AFFAIRS DIRECTOR: STEM AND HEAD REVISION SURGERY IN A (B)(6) WOMAN TREATED FOR AN IMMEDIATE POSTOPERATIVE FRACTURE FOLLOWING PRIMARY CEMENTLESS THA. THE INITIAL POSITION OF THE STEM AND CABLES CANNOT BE ASSESSED NOT HAVING THE POST OPERATIVE X-RAY. THIS EVENT MAY BE DUE TO UNDETECTED PROBLEMS ARISEN DURING PRIMARY OPERATION THAT MAY HAVE WEAKENED THE BONE WHICH WAS LATER FRACTURED BY WEIGHT BEARING AND LOADS, BUT OTHER UNKNOWN CONDITIONS MAY ALSO PLAY A ROLE. WE SEE NO REASON TO SUSPECT A FAULTY DEVICE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JUNE 2018; LOT 170028: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JUNE 2017. EXPIRATION DATE: 2022-06-01 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.

    Description of Event or Problem · 1

    A FEW DAYS AFTER PRIMARY SURGERY, A FRACTURE WAS NOTICED EVEN IF THERE WAS NO SIGN OF FRACTURE IMMEDIATELY POST OP AND NO TRAUMA REPORTED AS THE REASON FOR THE FRACTURE. THE FEMUR WAS CABLED, BUT THEN THE STEM LOOSENED AND SUBSIDED. THE STEM AND HEAD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419695 AMISTEM H HA COATED LAT STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 170028 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention