BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC FEMORAL STEMS

    MDR report key: 23876935 · Received December 23, 2025

    Report

    Report Number
    3005180920-2025-01324
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 16, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885594
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 DECEMBER 2025: STEM: MASTERLOC 01.39.010 MASTERLOC CEMENTLESS MECTAGRIP STEM STD SIZE10 (K151531) LOT 2347003: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2024. EXPIRATION DATE: 2029-MAR-24. 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 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 2526600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2025. EXPIRATION DATE: 2030-OCT-14. 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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A PRIMARY HIP ARTHROPLASTY ON (B)(6) 2025. POST-OP X-RAYS IDENTIFIED A LEG LENGTH DISCREPANCY, WITH THE LEFT LEG LONGER THAN THE RIGHT. ON THE SAME DATE, THE SURGEON PERFORMED A REVISION AND REVISED THE HEAD FROM A 36 MM M TO A 36 MM S AND REVISED THE MASTERLOC STEM FROM SIZE 10 TO SIZE 8. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531895 MASTERLOC FEMORAL STEMS MASTERLOC CEMENTLESS MECTAGRIP STEM STD SIZE10 LZO MEDACTA INTERNATIONAL SA 01.39.010 2347003 07630030885594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention