BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24882478 · Received April 15, 2026

    Report

    Report Number
    3005180920-2026-00321
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 15, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 MARCH 2026: BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 1902997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2019. EXPIRATION DATE: 2024-JUN-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E (K103721) LOT 1902885: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-APR-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 HAD A HIP DISLOCATION OF THE HEAD AND LINER IN THE RIGHT HIP AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF A FALL OR TRAUMA. AT ABOUT 6 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA MPACT SHELL AND LINER TO A COMPETITOR SHELL AND LINER, AND REVISED THE MEDACTA STEM TO A SAME SIZE STEM, AND 36MM BIOLOX HEAD TO A 28MM BIOLOX HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318488 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.208 1902997 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Required Intervention