BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15174135 · Received August 5, 2022

    Report

    Report Number
    3005180920-2022-00582
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    July 9, 2022
    Report Date
    August 5, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805103
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 JULY 2022: LOT 2102129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2021. EXPIRATION DATE: 2026-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 14 JULY 2022: BALL HEADS: BIPOLAR HEAD 25060.2844 BIPOLAR HEAD Ø28X44 (K091967) LOT 2114995: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2022. EXPIRATION DATE: 2027-01-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274645 BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 HIP COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.011 2102129 07630030805103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention