BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5

    MDR report key: 8814970 · Received July 23, 2019

    Report

    Report Number
    3005180920-2019-00595
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805172
    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 10 JULY 2019: LOT 082621/T: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 10 JULY 2019: LINER: MPACT 01.32.3248HCAT HOODED PE HC LINER Ø32/F (K132879) LOT 162916: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2016. EXPIRATION DATE: 2021-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER 2 YEARS AFTER PRIMARY. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609451 BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5 HIP METAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 082621/T 07630030805172

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention