BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5

    MDR report key: 16094458 · Received January 4, 2023

    Report

    Report Number
    3005180920-2022-01003
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 24, 2022
    Report Date
    January 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805127
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 DECEMBER 2022. LOT 2113049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2022. EXPIRATION DATE: 2026-12-13. 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. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: BALL HEADS: BIPOLAR HEAD 25060.2851 BIPOLAR HEAD Ø28X51 LOT. 2116131: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MARCH-2022. EXPIRATION DATE: 2027-02-21. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178279 BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5 HIP ACETABULAR METAL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.013 2113049 07630030805127

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention