MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

Model Number	01.22.403
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 november 2024.(b)(4) items manufactured and released on 17-jan-2024.Expiration date: 2028-jul-04.No anomalies found related to the problem.To date, 7 items of the same lot have been sold with no similar reported event during the period of review.Additional implants involved: liner: versafitcup cc trio 01.26.2852mhc double mobility hc liner ø 52/28 k092265 lot.2346561 batch review performed on 15 november 2024.(b)(4) items manufactured and released on 19-jul-2023.Expiration date: 2029-jan-02.No anomalies found related to the problem.To date, 65 items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.230h head biolox option ø 28 k131518 lot.2343520.Batch review performed on 15 november 2024.(b)(4) items manufactured and released on 13-dec-2023.Expiration date: 2028-nov-18.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.243a sleeve size xl k131518 lot.2345153.Batch review performed on 15 november 2024.(b)(4) items manufactured and released on 21-dec-2023.Expiration date: 2028-dec-02.No anomalies found related to the problem.To date, 6 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: a re-revision surgery of a total hip arthroplasty was performed due to infection.The available x-ray image reveals bone alterations in the proximal femur, with rarefaction particularly evident in the greater trochanter region.These findings can be interpreted as indirect signs of the reported infection.Infection is a recognized potential adverse event following any surgical procedure, especially in cases of revision surgery.At present, there is no evidence to suggest that the implanted devices are linked to the cause of the inf.Root cause: 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.
Event or Problem Description
Primary surgery was performed on (b)(6) 2023; hemiarthroplasty was probably implanted.On (b)(6) 2024, the patient was probably converted from hemi to total.On (b)(6) 2024, the patient was revised due to infection.Head, liner, and proximal part of the femoral component revised.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20817086
• Report Number: 3005180920-2024-01003
• Device Sequence Number: 8716858
• Product Code: LZO
• UDI-Device Identifier: 07630971263529
• UDI-Public: 07630971263529
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K201471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.22.403
• Device Lot Number: 2304281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown