BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4

    MDR report key: 18198433 · Received November 23, 2023

    Report

    Report Number
    3005180920-2023-00921
    Event Type
    Injury
    Date Received
    November 23, 2023
    Date of Event
    October 27, 2023
    Report Date
    November 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 NOVEMBER 2023: LOT 21C0007: 28 ITEMS MANUFACTURED AND RELEASED ON 15-JUNE-2021. EXPIRATION DATE: 2026-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 08 NOVEMBER 2023: LINER: IMPACT 01.32.3241HC10A FACE-CHANGING 10° PE HC LINER Ø32/D (K183582) LOT 1911122: 20 ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2020. EXPIRATION DATE: 2025-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 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 HAD A PRIMARY HIP SURGERY ON 23 MARCH 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240745 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 21C0007 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention