BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S

    MDR report key: 19890581 · Received August 2, 2024

    Report

    Report Number
    3005180920-2024-00620
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-JUL-2024. LOT 2237502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2022. EXPIRATION DATE: 2027-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 25-JUL-2024. STEM: M-VIZION 01.22.428 PROXIMAL BODY Ø24MM L 50MM LAT WITH HOLES (K201471) LOT 2302267: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2023. EXPIRATION DATE: 2028-06-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY COMPETITOR THA. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMORAL AND ACETABULAR BONE. THE SURGEON REVISED THE COMPETITOR'S STEM AND HEAD AND IMPLANTED SUCCESSFULLY A MEDACTA STEM AND HEAD. PRESENTLY ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR LINER WITH ANOTHER COMPETITOR LINER, AND THE MEDACTA PROXIMAL BODY AND HEAD WITH ANOTHER MEDACTA PROXIMAL BODY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957647 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2237502

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention