BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION DISTAL STEM Ø13MM L 140MM STRAIGHT

    MDR report key: 19826342 · Received July 25, 2024

    Report

    Report Number
    3005180920-2024-00541
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030884993
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 JUNE 2024. LOT 2115443: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2022. EXPIRATION DATE: 2027-JAN-12. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 28 JUNE 2024. STEM: M-VIZION 01.22.401 PROXIMAL BODY Ø20MM L 40MM STD WITH HOLES (K201471) LOT 2207732: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2022. EXPIRATION DATE: 2027-SEP-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. CLINICAL EVALUATION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: IT IS CONFIRMED THAT THE DISTAL STEM HAS SIGNS OF ABRASION AT THE PROXIMAL PORTION, CAUSED BY A METAL CERCLAGE WIRE THAT WAS DIRECTLY IN CONTACT WITH THE STEM. NO OBVIOUS CAUSES OF STEM-RELATED LOOSENING COULD BE IDENTIFIED, MOST LIKELY THE PREVIOUS FEMUR FRACTURE MAY HAVE COMPROMISED STEM OSSEOINTEGRATION OR THE METAL CERCLAGE WAS NOT STABLE (PREVENTING BONE HEALING). NO ADDITIONAL INVESTIGATION IS NEEDED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY. METAL CERCLAGE CAME INTO CONTACT WITH THE STEM CAUSING ABRASION. CERCAGLE WAS USED TO FIX A FEMORAL FRACTURE THAT OCCURRED WITH COMPETITOR COMPONENTS (THE PATIENT HAD A PRIMARY SURGERY WITH COMPETITOR'S COMPONENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302893 STEM: M-VIZION DISTAL STEM Ø13MM L 140MM STRAIGHT HIP FEMUR DISTAL STEM LZO MEDACTA INTERNATIONAL SA 2115443 07630030884993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention