BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 22 SIZE M 0

    MDR report key: 14165804 · Received April 21, 2022

    Report

    Report Number
    3005180920-2022-00274
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 19, 2022
    Report Date
    April 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805479
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 APRIL 2022. LOT 2010474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2021. EXPIRATION DATE: 2026-01-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: BIPOLAR HEAD 25060.2241 BIPOLAR HEAD Ø22X41 (K091967) LOT. 1905687. BATCH REVIEW PERFORMED ON 20 APRIL 2022. LOT 1905687: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2019. EXPIRATION DATE: 2024-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958646 BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 22 SIZE M 0 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.123 2010474 07630030805479

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention