BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE3

    MDR report key: 7182192 · Received January 11, 2018

    Report

    Report Number
    3005180920-2017-00826
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    November 11, 2017
    Report Date
    February 28, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 JANUARY 2018. LOT 170014:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JUNE 2017. EXPIRATION DATE: 2022-05-29. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED ON 30 JANUARY 2018 BY R&D PRODUCT MANAGER: THE STEM HAD SOME SIGNS ON THE NECK DUE TO THE REVISION, WHILE THE HA COATING WAS TOTALLY PRESENT ON THE BODY, EXCEPT ONE PART IN THE AREA OF THE NECK CUT. FROM THE RECEIVED PART IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    REVISION OF AMISTEM H DUE TO A POST-OPERATIVE PERIPROSTHETIC FRACTURE. THERE WAS A TINY CRACK ON THE POST OP X-RAY, BUT IT WAS DONE AT THE WEEKEND AND SHE WAS SENT HOME. IT THEN FRACTURED DOING PHYSIO 5 DAYS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26474 AMISTEM H HA COATED STD STEM SIZE3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 170014 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention