BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24376301 · Received February 18, 2026

    Report

    Report Number
    3005180920-2026-00128
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 18, 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 03 FEBRUARY 2026. BALL HEADS: MECTACER 01.29.204 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S (K112115) LOT 2433561: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2024. EXPIRATION DATE: 01-DEC-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. CUP: MPACT 01.32.148DH ACETABULAR SHELL D 48 TWO-HOLES (K132879) LOT 2009431: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2021. EXPIRATION DATE: 12-JAN-2026. 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 01.32.3239HCT FLAT PE HC LINER D 32/C (K103721) LOT 2424771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2024. EXPIRATION DATE: 10-OCT-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. STEM: SMS SOLID 01.36.043 SMS SOLID STEM STD SIZE3 (K181693) LOT 2317572: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2023. EXPIRATION DATE: 15-NOV-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. 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 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND MRSA AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL PRIMARY IMPLANTS FOR ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439503 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.204 2433561 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention