BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24964781 · Received April 23, 2026

    Report

    Report Number
    3005180920-2026-00343
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 23, 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

    BATCH REVIEW PERFORMED ON 07 APR 2026 BALL HEADS: MECTACER 01.29.210 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L LOT 164979 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2016. EXPIRATION DATE: 2021-OCT-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: MASTERLOC 01.39.208 MASTERLOC CEMENTLESS MECTAGRIP STEM LAT SIZE8 LOT 168824 (K151531): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2017. EXPIRATION DATE: 2022-APR-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. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER D 36/F LOT 174525 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2017. EXPIRATION DATE: 2022-NOV-27. 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 01.32.156DH ACETABULAR SHELL D 56 TWO-HOLES LOT 171755 (K132879): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2017. EXPIRATION DATE: 2022-SEP-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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

    REVISION SURGERY DUE TO INFECTION ABOUT 8 YEARS AFTER PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, THE ACETABULAR SHELL, LINER AND THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249021 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L LZO MEDACTA INTERNATIONAL SA 01.29.210 164979 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention