BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 0

    MDR report key: 10928283 · Received December 1, 2020

    Report

    Report Number
    3005180920-2020-00854
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 NOVEMBER 2020: LOT 162246: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-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

    THE PATIENT CAME IN AFTER 2 YEARS AND 7 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE AMISTEM-H STD. # 0 WITH A QUADRA H SN STANDARD #0, AND THE 32MM BIOLOX DELTA HEAD S, WITH A 32MM BIOLOX DELTA HEAD M(THE LINER WAS NOT REVISED). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395869 STEM: AMISTEM H HA COATED STD STEM SIZE 0 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.130 162246 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention