BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 22 SIZE M 0

    MDR report key: 8235432 · Received January 10, 2019

    Report

    Report Number
    3005180920-2018-01083
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805479
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JANUARY 2019. LOT: 178432: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 FEBRUARY 2018 . EXPIRATION DATE: 2023-02-02. 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. OTHER DEVICE INVOLVED: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2, REFERENCE: 01.26.2246 MHC (K092265). LOT: 174320: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 NOVEMBER 2017. EXPIRATION DATE: 2022-10-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27207 COCR BALL HEAD 12/14 Ø 22 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 178432 07630030805479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention