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: 18535548 · Received January 18, 2024

    Report

    Report Number
    3005180920-2023-01072
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 19, 2023
    Report Date
    January 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805103
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-DEC-2023. LOT 2111666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2021. EXPIRATION DATE: 2026-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE COMPLAINT: BATCH REVIEW PERFORMED ON 20-DEC-2023. BALL HEADS: BIPOLAR HEAD 25060.2854 BIPOLAR HEAD Ø28X54 (K091967) LOT 2242648: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2023. EXPIRATION DATE: 2028-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 WEEKS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON EXPLANTED THE COCR HEAD AND BIPOLAR HEAD AND CONVERTED THE PATIENT TO A TOTAL HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830642 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 2111666 07630030805103

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention