BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 8619675 · Received May 17, 2019

    Report

    Report Number
    3005180920-2019-00392
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 19, 2019
    Report Date
    May 17, 2019
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 MAY 2019: LOT 183774: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2018. EXPIRATION DATE: 2023-09-27. 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 ONE OTHER DEVICE WAS INVOLVED IN THE EVENT BALL HEADS: BIPOLAR HEAD 25060.2852 BIPOLAR HEAD Ø28X52 LOT. 180856 (K091967): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2018. EXPIRATION DATE: 2023-06-03. 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 AFTER 2 MONTHS AND 18 DAYS FORM THE PRIMARY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COCR HEAD AND THE BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412517 BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0 HIP COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 183774 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention