BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE XL +7

    MDR report key: 7468210 · Received April 27, 2018

    Report

    Report Number
    3005180920-2018-00283
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    March 30, 2017
    Report Date
    April 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805134
    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 25 APRIL 2018; COCR BALL HEAD 12/14 Ø 28 SIZE XL +7 LOT 168273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2017. EXPIRATION DATE: 2022-04-02; 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 Ø28X51 REFERENCE 25060.2851 (K091967); LOT 164204: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 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 SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO HEMATOMA 3 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE BIPOLAR HEAD AND THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312051 COCR BALL HEAD 12/14 Ø 28 SIZE XL +7 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 168273 07630030805134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention