BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 32 SIZE M 0

    MDR report key: 10425795 · Received August 19, 2020

    Report

    Report Number
    3005180920-2020-00521
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805165
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 AUGUST 2020: LOT 090209: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2009. EXPIRATION DATE: 2014-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 29 JULY 2020: LINER: VERSAFITCUP CC TRIO 01.26.3248HCT FLAT PE HC LINER Ø 32 / F (K103352) LOT 111547: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2011. EXPIRATION DATE: 2016-06-30. 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 SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HIP METALLIC BALL HEAD FROM THE LINER. 7 YEARS AND 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE CUP AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE METALLIC HEAD WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892986 COCR BALL HEAD 12/14 32 SIZE M 0 HIP COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.022 090209 07630030805165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention