BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX OPTION 28

    MDR report key: 11782890 · Received May 6, 2021

    Report

    Report Number
    3005180920-2021-00360
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 6, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809323
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 APRIL 2021: LOT 170726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUNE-2017. EXPIRATION DATE: 2022-06-06. 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. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 12 APRIL 2021: BALL HEADS: MECTACER 01.29.240A SLEEVE SIZE S (K131518), LOT 167061: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DIC-2016. EXPIRATION DATE: 2021-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT SINCE 2017.

    Description of Event or Problem · 1

    SIGNS OF INFECTION 2 YEARS AFTER FIRST REVISION SURGERY DUE TO INFECTION. WASHOUT PERFORMED AND HEAD REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683747 BALL HEADS: MECTACER BIOLOX OPTION 28 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.230H 170726 07630030809323

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention