BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5

    MDR report key: 17388488 · Received July 25, 2023

    Report

    Report Number
    3005180920-2023-00603
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 7, 2023
    Report Date
    July 25, 2023
    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 (B)(6), 2023: LOT 1907338: (B)(4), MANUFACTURED AND RELEASED ON (B)(6), 2020. EXPIRATION DATE: 2025-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 113 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6), 2023: BALL HEADS: BIPOLAR HEAD 25060.2844 BIPOLAR HEAD Ø28X44 (K091967) LOT 2201492: 34 ITEMS MANUFACTURED AND RELEASED ON 19-APRIL-2022. EXPIRATION DATE: 2027-03-31. 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.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH 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 CERAMIC AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946574 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 1907338 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention