BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 22 SIZE M 0

    MDR report key: 8260596 · Received January 18, 2019

    Report

    Report Number
    3005180920-2018-01114
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    December 20, 2018
    Report Date
    January 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805479
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JANUARY 2019: LOT 182504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2018. EXPIRATION DATE: 2023-06-20. 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. OTHER DEVICE INVOLVED: BIPOLAR HEAD Ø22X41 REFERENCE 25060.2241 (K091967). LOT 154911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2015. EXPIRATION DATE: 2020-10-18. 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, 5 WEEKS AFTER PRIMARY SURGERY, DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON CONVERTED THE BIPOLAR HIP TO A TOTAL HIP AND REVISED THE STEM, COCR HEAD AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54515 COCR BALL HEAD 12/14 Ø 22 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 182504 07630030805479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention