BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 19605523 · Received June 25, 2024

    Report

    Report Number
    3005180920-2024-00437
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 31 MAY 2024: LOT 2339382: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2023. EXPIRATION DATE: 2028-10-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2339902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 2028-10-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH FROM 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481914 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 2339382 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention