BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L

    MDR report key: 15750884 · Received November 8, 2022

    Report

    Report Number
    3005180920-2022-00846
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809149
    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 27-OCT-2022: LOT 1908980: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2020. EXPIRATION DATE: 2025-01-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 3 OTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 27-OCT-2022: LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28 (K092265) LOT 2201631: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2022. EXPIRATION DATE: 2027-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 14 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251630 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.203 1908980 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention