BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12890288 · Received November 30, 2021

    Report

    Report Number
    3005180920-2021-00961
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    November 12, 2021
    Report Date
    November 30, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805219
    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 15.NOVEMBER.2021: LOT 2104424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-07-2021. EXPIRATION DATE: 2026-06-22 NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G (K103721) LOT. 2100163. BATCH REVIEW PERFORMED ON 15.NOVEMBER.2021: LOT 2100163: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-FEB-2021. EXPIRATION DATE: 2026-01-19. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 0

    THE PATIENT CAME IN 3 DAYS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON IMPLANTED A LARGER DM CUP WITH MORE ANTEVERSION PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794634 BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 36 SIZE M 0 METAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.031 2104424 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention