BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 20977487 · Received December 19, 2024

    Report

    Report Number
    3005180920-2024-01093
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-DEC-2024: LOT 2246436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-01-2023. EXPIRATION DATE: 2028-01-12. 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 IMPLANTS REVISED: BATCH REVIEW PERFORMED ON 06-DEC-2024 ON STEM: M-VIZION 01.22.402 PROXIMAL BODY Ø20MM L 50MM STD WITH HOLES (K201471) LOT. 2311405: LOT 2311405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-09-2023. EXPIRATION DATE: 2028-08-27. 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. BATCH REVIEW PERFORMED ON 06-DEC-2024 ON BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2418024: LOT 2418024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-07-2024. EXPIRATION DATE: 2029-06-20. 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. BATCH REVIEW PERFORMED ON 06-DEC-2024 ON LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 2343828: LOT 2343828: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-12-2023. EXPIRATION DATE: 2028-11-20. 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. BATCH REVIEW PERFORMED ON 06-DEC-2024 ON CUP: MPACT 01.38.358MH ACETABULAR SHELL Ø58 MULTI-HOLE THIN (K202568) LOT. 2205839: LOT 2205839: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-04-2022. EXPIRATION DATE: 2027-04-06. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284170 M-VIZION FEMORAL REVISION SYSTEM HIP CEMENTLESS DISTAL STEM LZO MEDACTA INTERNATIONAL SA 01.22.102 2246436

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention