BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR 01.25.011 COCR BALL HEAD 12/14 28 SIZE S -3.5

    MDR report key: 12475408 · Received September 15, 2021

    Report

    Report Number
    3005180920-2021-00741
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805103
    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 18 AUGUST 2021: LOT 2010461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2021. EXPIRATION DATE: 2025-DEC-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 18 AUGUST 2021: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER 28/DMG (K092265) LOT 2100184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MARCH-2021. EXPIRATION DATE: 2026-MARCH-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 94 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369889 COCR 01.25.011 COCR BALL HEAD 12/14 28 SIZE S -3.5 HIP BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.011 2010461 07630030805103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention