BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11162451 · Received January 13, 2021

    Report

    Report Number
    3005180920-2021-00048
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 12 JANUARY 2021: LOT 2001873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2020. EXPIRATION DATE: 2025-06-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 12 JANUARY 2021: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2003334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JULY-2020. EXPIRATION DATE: 2025-06-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER, 2 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56199 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2001873 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention