BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5

    MDR report key: 8919936 · Received August 22, 2019

    Report

    Report Number
    3005180920-2019-00705
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 22, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805127
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31-JULY-2019. LOT 166592: 150 ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2017. EXPIRATION DATE: 2022-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 OTHER SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED. BATCH REVIEW FOR BALL HEADS: BIPOLAR HEAD 25060.2851 BIPOLAR HEAD Ø28X51 LOT. 164204 (K091967): 7 ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2016. EXPIRATION DATE: 2021-09-25. 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 AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE 28MM COCR HEAD L WITH A 28MM COCR HEAD L AND REVISED THE BIPOLAR HEAD 51MM/28 WITH A BIPOLAR HEAD 51MM/28 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716768 COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 166592 07630030805127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention