BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD Ø28X51

    MDR report key: 14039889 · Received April 7, 2022

    Report

    Report Number
    3005180920-2022-00246
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843730
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 APRIL 2022: LOT 186812: (B)(4). EXPIRATION DATE: 2023-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL ITEMS INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 178983. BATCH REVIEW PERFORMED ON 05 APRIL 2022: LOT 178983: (B)(4). EXPIRATION DATE: 2023-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). STEM: QUADRA-P 01.12.232 QUADRA-P CEMENTED LAT STEM SIZE 2 (K192827) LOT. 2002222 BATCH REVIEW PERFORMED ON 06 APRIL 2022: LOT 2002222: (B)(4). EXPIRATION DATE: 2025-05-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO INTRA-PROSTHETIC DISLOCATION. SEVERAL ATTEMPTS OF CLOSED REDUCTION WERE PERFORMED ON THE PATIENT TO TRY TO RESOLVE THE DISLOCATION. THE SURGEON REVISED THE BIPOLAR HEAD, CERAMIC HEAD, AND STEM WHICH APPEARED TO BE LOOSE DUE TO AGGRESSIVE MANEUVERS OF CLOSE REDUCTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912327 BALL HEADS: BIPOLAR HEAD Ø28X51 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2851 186812 07630030843730

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention