BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: 25060.2846 BIPOLAR HEAD 28X46

    MDR report key: 10161542 · Received June 17, 2020

    Report

    Report Number
    3005180920-2020-00336
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    May 15, 2020
    Report Date
    July 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843631
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR:THE BIPOLAR CUP HAD THE PLASTIC RING REMOVED; IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT, BUT IT COULD BE PROBABLY DUE TO A LEVER ARM THAT CAUSED THE REMOVAL OF THE RING.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 MAY 2020: LOT 153017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 27 MAY 2020: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M 0 (K112115) LOT 18C0004: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2018. EXPIRATION DATE: 2023-09-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISASSOCIATION OF THE BIPOLAR HEAD FROM THE BIOLOX HEAD THAT WAS CAUSED WHEN THE PATIENT WAS GETTING OUT OF BED. THE SURGEON CONVERTED THE PATIENT FROM A BIPOLAR HIP TO A TOTAL HIP 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629844 BALL HEADS: 25060.2846 BIPOLAR HEAD 28X46 HIP BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2846 153017 07630030843631

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention