BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0

    MDR report key: 20298883 · Received September 25, 2024

    Report

    Report Number
    3005180920-2024-00785
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2024: LOT 2000875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2020. EXPIRATION DATE: 2025-06-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2024: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT 2003337: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JULY-2020. EXPIRATION DATE: 2025-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND INER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292412 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2000875 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention