BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID COLLARED STEM STD SIZE 12

    MDR report key: 19892475 · Received August 2, 2024

    Report

    Report Number
    3005180920-2024-00601
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K203041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 JULY 2024. LOT 2206145: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT REPORTED PAIN DUE TO A SUBSIDED STEM. SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985099 STEM: SMS SOLID COLLARED STEM STD SIZE 12 HIP STEM SOLID COLLARED LZO MEDACTA INTERNATIONAL SA 2206145

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention