BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD 25060.2845 BIPOLAR HEAD Ø28X45

    MDR report key: 15348737 · Received September 2, 2022

    Report

    Report Number
    3005180920-2022-00666
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 2, 2022
    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 · 0

    BATCH REVIEW PERFORMED ON 08 AUGUST 2022: LOT 2002016: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2020. EXPIRATION DATE: 2025-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 08 AUGUST 2022: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2009385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2021. EXPIRATION DATE: 2026-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201954 BALL HEADS: BIPOLAR HEAD 25060.2845 BIPOLAR HEAD Ø28X45 HIP BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2845 2002016 07630030843617

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention