BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.142 HA COATED LAT STEM SIZE 2

    MDR report key: 17257962 · Received July 5, 2023

    Report

    Report Number
    3005180920-2023-00470
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 160756: 60 ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2016. EXPIRATION DATE: 2021-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION WAS CONFIRMED AS STAPH. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418871 STEM: AMISTEM H 01.18.142 HA COATED LAT STEM SIZE 2 HIP COATED LAT STEM LZO MEDACTA INTERNATIONAL SA 01.18.142 160756 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention