BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 25123205 · Received May 8, 2026

    Report

    Report Number
    3005180920-2026-00379
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 MAY 2026: MECTACER 01.29.204 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S (K112115) LOT. 2520668: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2025. EXPIRATION DATE: 2030-JUL-30. 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. MPACT 01.32.3237HCT FLAT PE HC LINER D 32/B (K112115) LOT. 2526515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2025. EXPIRATION DATE: 2030-NOV-11. 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. R&D ANALYSIS VISUAL INSPECTION PERFORMED ON 29 APRIL 2026. FROM THE RECEIVED PART IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT; NO IMPLANT DEFECTS WERE NOTICED ON THE DEVICE AND THE ONLY VISIBLE SIGN WAS A BLACK SPOT PROBABLY OCCURRED DURING THE REVISION AND THE CONTACT WITH THE METALLIC INSTRUMENTS. ROOT CAUSE: FROM THE RECEIVED PART AND THE AVAILABLE INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE OF THE EVENT; NO IMPLANT DEFECTS WERE OBSERVED ON THE DEVICE, THE ONLY VISIBLE SIGN BEING A BLACK SPOT LIKELY CAUSED DURING THE REVISION DUE TO CONTACT WITH METALLIC INSTRUMENTS, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING-RELATED ISSUE NOR ANY EVIDENCE THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO IMPLANT DISLOCATION AFTER ABOUT 2 MONTHS FROM THE PRIMARY SURGERY. DURING THE SURGERY THE HEAD WAS CHANGED FROM SIZE S TO SIZE M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54463 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.204 2520668 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention