BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X45

    MDR report key: 9605381 · Received January 20, 2020

    Report

    Report Number
    3005180920-2019-01162
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    December 24, 2019
    Report Date
    January 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843617
    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 DECEMBER 2019. LOT 1900862: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-05-27. 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 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT. 1903461. BATCH REVIEW PERFORMED ON 27 DECEMBER 2019. LOT 1903461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-17. 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

    THE PATIENT CAME IN, 23 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE BIPOLAR HEAD 45MM/28 AND 28MM COCR HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71647 BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X45 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2845 1900862 07630030843617

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention