BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 19069662 · Received April 9, 2024

    Report

    Report Number
    3005180920-2024-00190
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 13, 2024
    Report Date
    March 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888625
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 MARCH 2024 LOT 1902970: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 MARCH 2025. LOT: 2218128: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2023. EXPIRATION DATE: 2027-12-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CORRECTION: ON (B)(6) 2025, A COMPLAINT RELATED TO A SECOND REVISION DUE TO THE STEM MOBILIZATION OF THE SAME PATIENT AS THIS COMPLAINT WAS REPORTED. THE LISTED STEM WAS THE SAME IN BOTH COMPLAINTS. AFTER INVESTIGATION, IT WAS FOUND THAT THE STEM PREVIOUSLY REPORTED IN THIS COMPLAINT WAS THE ONE IMPLANTED AND NOT REVISED. ALL THE MDR FIELDS HAVE BEEN MODIFIED ACCORDINGLY. PRIMARY SURGERY ON (B)(6) 2023, REF. (B)(4), LOT. 2218128 IMPLANTED. 1ST REVISION SURGERY ON (B)(6) 2024, REF. (B)(4), LOT: 2218128 EXPLANTED, REF. (B)(4), LOT: 1902970, IMPLANTED. 2ND REVISION SURGERY ON (B)(6) 2025, REF. (B)(4), LOT: 1902970 EXPLANTED (MDR: (B)(4).

    Description of Event or Problem · 0

    AT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    AT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456414 SMS STEM SMS SOLID STEM STD SIZE 3 LZO MEDACTA INTERNATIONAL SA 2218128 07630030888625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention