BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 25077220 · Received May 5, 2026

    Report

    Report Number
    3005180920-2026-00364
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 5, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION FEW MONTHS AFTER PRIMARY CEMENTLESS THA, AN INFECTION ACCURS AROUND THE ACETABULUM AND THE CUP IS REVISED. NO REASON TO SUSPECT A FAULTY OR DEFECTIVE DEVICE AT THE ORIGIN OF THIS ADVERSE EVENT, WHOSE ROOT CAUSE SHOULD BE DEFINED AS EARLY DEEP INFECTION. BATCH REVIEW PERFORMED ON 10 APR 2026 BALL HEADS: MECTACER 01.29.210 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L (K112115) LOT. 2345140: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2023. EXPIRATION DATE: 2028-NOV-20. 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 01.32.3652HCT FLAT PE HC LINER D 36/G LOT. 2503779 (K103721) LOT 2503779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APR-2025. EXPIRATION DATE: 2030-MAR-12. 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 3D METAL 01.38.060DH ACETABULAR SHELL D 60 TWO-HOLE (K171966) LOT. 1907450B LOT 1907450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-SEP-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. FROM THIS LOT, (B)(4) ITEMS WERE RE-STERILIZED; AS OF TODAY, (B)(4) HAVE BEEN SOLD. ROOT CAUSE:INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. THE ROOT CAUSE CAN BE IDENTIFIED AS AN EARLY DEEP INFECTION; 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

    REVISION SURGERY DUE TO INFECTION AFTER 6 MONTHS FROM PRIMARY SURGERY. THE SURGEON UPSIZED THE MPACT 3D METAL SHELL, MPACT LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412512 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L LZO MEDACTA INTERNATIONAL SA 01.29.210 2345140 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention