BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 18371302 · Received December 21, 2023

    Report

    Report Number
    3005180920-2023-01062
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 6, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805219
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2023: LOT 2246992: 100 ITEMS MANUFACTURED AND RELEASED ON 05-APR-2023. EXPIRATION DATE: 2028-03-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION 1 MONTH AND A HALF AFTER THE PRIMARY DUE TO JOINT LUXATION (LINER IS FROM A COMPETITOR). THE MEDACTA HEAD WAS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169231 BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 HIP COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 2246992 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention