BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24208596 · Received January 29, 2026

    Report

    Report Number
    3005180920-2026-00055
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 13, 2026
    Report Date
    January 29, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809149
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 JANUARY 2026. BALL HEADS: MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT 2515046: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2025. EXPIRATION DATE: 04-JUN-2030. 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: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER D 28/DMG (K09226) LOT 2523294: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2025. EXPIRATION DATE: 21-SEP-2030. 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: AMISTEM P 01.18.411 AMISTEM-P LAT STEM SIZE1 (K173794) LOT 1908458C: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2025. EXPIRATION DATE: 19-JAN-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP 01.26.54MB VERSAFITCUP METALBACK DM D 54 MM (K083116) LOT 2515046: 100 ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2025. EXPIRATION DATE: 04-JUN-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 80 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 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY. ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277067 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L LZO MEDACTA INTERNATIONAL SA 01.29.203 2515046 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention