BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 25148979 · Received May 12, 2026

    Report

    Report Number
    3005180920-2026-00433
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888670
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 ARPIL 2026 STEM: SMS SOLID 01.36.048 SMS SOLID STEM STD SIZE 8 (K181693) LOT 2248976: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2023. EXPIRATION DATE: 05-APR-2028. 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. BALL HEADS: MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT 2425507: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2024. EXPIRATION DATE: 11-SEP-2029. 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. LINER: MPACT DM 01.32.152MB MPACT DM ACETABULAR SHELL D 52 (K143453) LOT 2417831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2024. EXPIRATION DATE: 20-NOV-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2(B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SMS SOLID STEM SIZE8 TO AN AMISTEM-C SIZE3, REVISED THE 28MM BIOLOX HEAD L TO A 40MM BIOLOX HEAD XL, AND REVISED THE D 28/DMF DOUBLE MOBILITY LINER TO A FACE CHANGING 10° HC LINER D 40/G. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376859 SMS STEM SMS SOLID STEM STD SIZE8 LZO MEDACTA INTERNATIONAL SA 01.36.048 2248976 07630030888670

    Patients

    Seq Age Sex Outcome Treatment
    1