BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 7206119 · Received January 19, 2018

    Report

    Report Number
    3005180920-2017-00859
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 21, 2017
    Report Date
    January 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 JANUARY 2018: LOT 168271: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 MAY 2017. EXPIRATION DATE: 2022-04-23 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. BIPOLAR HEAD Ø28X44 REFERENCE 25060.2844 (K091967): LOT. 171298: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 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 SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49097 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 168271 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention