BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE M

    MDR report key: 10331241 · Received July 28, 2020

    Report

    Report Number
    3005180920-2020-00473
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 7, 2020
    Report Date
    July 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 06 JULY 2020: LOT 1906478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2019. EXPIRATION DATE: 2024-10-16. 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. OTHER DEVICES INVOLVED IN THE EVENT: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F LOT. 1904359 (K122641). BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 06 JULY 2020: LOT 1904359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUNE-2019. EXPIRATION DATE: 2024-06-09. 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 1 MONTH AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795430 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.213 1906478 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention