BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE S

    MDR report key: 9971254 · Received April 17, 2020

    Report

    Report Number
    3005180920-2020-00245
    Event Type
    Injury
    Date Received
    April 17, 2020
    Date of Event
    March 18, 2020
    Report Date
    April 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 MARCH 2020: LOT 1811838: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2019. EXPIRATION DATE: 2024-03-23. 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, 8 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA 36MM BIOLOX DELTA HEAD S WITH A MEDACTA 28MM BIOLOX DELTA HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435180 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE S CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.208 1811838 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention