BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L +4

    MDR report key: 12431479 · Received September 7, 2021

    Report

    Report Number
    3005180920-2021-00710
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2021: LOT 2009397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2021. EXPIRATION DATE: 2026-01-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2021: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2013100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2025-12-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    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 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330893 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L +4 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.206 2009397 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention