BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5

    MDR report key: 8883103 · Received August 12, 2019

    Report

    Report Number
    3005180920-2019-00683
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 18, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805103
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 177464 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 FEBRUARY 2018. EXPIRATION DATE: 2023-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED BALL HEADS: BIPOLAR HEAD 25060.2850 BIPOLAR HEAD Ø28X50 LOT. 176898 (K091967): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 MARCH 2018. EXPIRATION DATE: 2023-02-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 2 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY FRACTURED ACETABULUM. PRIOR TO THE PRIMARY SURGERY, THE PATIENT HAD SEVERE BONE LOSS IN HER FEMORAL HEAD WHICH IN TURN CAUSED EROSION OF HER ACETABULUM. THE BIPOLAR HEAD UNDER STRESS PUSHED THROUGH THE ACETABULAR WALL. THE SURGEON REVISED BIPOLAR HEAD AND THE COCR HEAD SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679793 BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 HIP COCR HEAD JDI MEDACTA INTERNATIONAL SA 177464 07630030805103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention