BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD Ø28X44

    MDR report key: 8377330 · Received February 28, 2019

    Report

    Report Number
    3005180920-2019-00111
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    January 30, 2019
    Report Date
    February 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843594
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 FEBRUARY 2019: LOT 181370: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUL-2018. EXPIRATION DATE: 2023-07-02. 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 IMPLANT INVOLVED: BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT 182500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2018. EXPIRATION DATE: 2023-06-21. 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 AND WASHOUT PERFORMED ONE MONTH AFTER PRIMARY SURGERY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE BIPOLAR HEAD AND THE COCR HEAD HAVE BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173060 BALL HEADS: BIPOLAR HEAD Ø28X44 HIP BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 181370 07630030843594

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention