BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED LAT STEM SIZE 7

    MDR report key: 7629555 · Received June 22, 2018

    Report

    Report Number
    3005180920-2018-00446
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 22, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804236
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 JUNE 2018; LOT 162264: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 JUNE 2016. EXPIRATION DATE: 2021-06-20 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

    WE WERE INFORMED ON (B)(6) 2018 THAT A PATIENT CAME IN COMPLAINING OF PAIN AND TROUBLE WALKING. THE STEM MAY HAVE SUBSIDED. THE SURGEON PLANS TO TRY A LONGER HEAD, THEN EXCHANGE STEM IF THAT DOES NOT WORK. ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON IMPLANTED A LONGER HEAD AND AS THE STEM SUBSIDED AND SETTLED IT RETROVERTED A BIT MORE. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473630 AMISTEM H HA COATED LAT STEM SIZE 7 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 162264 07630030804236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention