BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23837338 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01290
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 18, 2025
    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 16 DECEMBER 2025. BALL HEADS: MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT 2515737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUNE-2025. EXPIRATION DATE: 2030-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: AMISTEM P 01.18.403 AMISTEM-P STD. SIZE 3 (K173794) LOT 2502526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAY-2025. EXPIRATION DATE: 2030-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER D 28/DMD LOT. 2508202 LOT 2508202: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2025. EXPIRATION DATE: 2030-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.148MB MPACT DM ACETABULAR SHELL D 48 (K143453) LOT 2500934: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2025. EXPIRATION DATE: 2030-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED EVERYTHING AND PUT IN COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274140 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L LZO MEDACTA INTERNATIONAL SA 01.29.203 2515737 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention