BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 17020054 · Received May 30, 2023

    Report

    Report Number
    3005180920-2023-00384
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 2, 2023
    Report Date
    May 30, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 MAY 2023. LOT 2113048: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2022. EXPIRATION DATE: 2026-12-14. 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: BALL HEADS: BIPOLAR HEAD 25060.2846 BIPOLAR HEAD Ø28X46 (K091967) LOT 2116123: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MARCH-2022. EXPIRATION DATE: 2027-02-15. 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 12 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449051 BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0 HIP FEMORAL METALLIC HEAD JDI MEDACTA INTERNATIONAL SA 01.25.012 2113048 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention