BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT

    MDR report key: 20043509 · Received August 22, 2024

    Report

    Report Number
    3005180920-2024-00647
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030877162
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JUL 2024: LOT 1901216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. 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. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 31 JUL 2024: STEM: M-VIZION 01.22.101 DISTAL STEM Ø12MM L 140MM STRAIGHT (K170690) LOT 2101124: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2021. EXPIRATION DATE: 2026-07-22. 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. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 2214382: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-09-20. 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 LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT 2202286: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2022. EXPIRATION DATE: 2027-03-13. 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

    AT 1 YEAR AND 7 MONTHS FROM THE MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR CUP WITH A MEDACTA CUP, AND REVISED THE MEDACTA STEM, PROXIMAL BODY, HEAD, LINER WITH MEDACTA IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741822 M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT HIP MODULAR STEM PROXIMAL BODY LZO MEDACTA INTERNATIONAL SA 1901216 07630030877162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention