BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9848074 · Received March 18, 2020

    Report

    Report Number
    3005180920-2020-00171
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1904652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEPT-2019. EXPIRATION DATE: 2024-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 MONTH AFTER PRIMARY FOR INFECTION. WASH OUT, LINER AND HEAD SWAP PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311487 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 1904652 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention