BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 14344592 · Received May 10, 2022

    Report

    Report Number
    3005180920-2022-00362
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    March 8, 2022
    Report Date
    June 3, 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 14 APRIL 2022: LOT 141463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUN-2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 APRIL 2022: LOT 141463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUN-2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D MANAGER: DURING THE ANALYSIS IT IS EVALUATED THAT WHOLE HA COATING ON THE STEM BODY HAS BEEN ABSORBED BY PATIENT BONE AS EXPECTED. SOME SIGNS 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

    AT 7 YEARS AND 5 MONTHS REVISION SURGERY PERFORMED FOR STEM LOOSENING. THE PATIENT HAD PAIN IN THE LEFT THIGH ESPECIALLY DURING EXTERNAL ROTATION. NON SINTHOMS IN THE RIGHT LEG.

    Description of Event or Problem · 0

    AT 7 YEARS AND 5 MONTHS REVISION SURGERY PERFORMED FOR STEM LOOSENING. THE PATIENT HAD PAIN IN THE LEFT THIGH ESPECIALLY DURING EXTERNAL ROTATION. NON SINTHOMS IN THE RIGHT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565989 STEM: AMISTEM H HA COATED STD STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.133 141463 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention