BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22903493 · Received August 27, 2025

    Report

    Report Number
    3005180920-2025-00773
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JULY 2025. MECTACER 01.29.204 MECTACER BIOLOX DELTA BALL HEADS LOT. 2434492: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2025. EXPIRATION DATE: 9-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. AMISTEM C 01.18.151 AMISTEM-C STD. SIZE 1 (K103189) LOT. 2430109: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2025. EXPIRATION DATE: 17-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. MPACT 01.32.146DHT ACETABULAR SHELL Ø46 TWO-HOLES T (K230011) LOT. 2418544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2024. EXPIRATION DATE: 21-OCT-2029. NO ANOMALIES WERE 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. MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K103721) LOT. 2424770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2024. EXPIRATION DATE: 10-OCT-2029. NO ANOMALIES WERE 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

    AFTER 2 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498806 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER BIOLOX DELTA BALL HEADS LZO MEDACTA INTERNATIONAL SA 01.29.204 2434492 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention