BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3

    MDR report key: 14733655 · Received June 17, 2022

    Report

    Report Number
    3005180920-2022-00457
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 3, 2022
    Report Date
    September 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 MAY 2022. LOT 110842: 60 ITEMS MANUFACTURED AND RELEASED ON 13-APR-2011. EXPIRATION DATE: 2016-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. SINCE RELEASE TO DATE, 57 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER: DURING THE ANALYSIS IT IS EVALUATED THAT APPROXIMATELY THE FIRST HALF OF THE STEM BODY IS STILL COVERED WITH HA COATING. THIS IN UNEXPECTED, MEANING THAT THE STEM WAS NOT CORRECTLY ONSTEOINTEGRATED WITH PATIENT BONE. SOME SINGS AND SCRATCHES ARE PRESENT ON THE STEM NECK PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED STEM LOOSENING.

    Description of Event or Problem · 0

    PRIMARY SURGERY PERFORMED ON 23 MAY 2011. THE PATIENT WAS REPORTING PAIN SINCE OCTOBER 2021. ABOUT 11 YEARS AFTER THE PRIMARY SURGERY, STEM WAS REVISED DUE TO ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350225 STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3 HIP COATED STEM LZO MEDACTA INTERNATIONAL SA 01.18.133 110842 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention