MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; DISTAL STEM Ø13MM

Model Number	01.22.102
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 october 2024: lot 2336074: (b)(4) items manufactured and released on 29-jan-2024.Expiration date: 2029-01-10.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 component involved and revised: batch review performed on 28 october 2024: stem: m-vizion 01.22.402 proximal body ø20mm l 50mm std with holes (k201471) lot 2312600: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 2028-10-24.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.Conclusions: there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in reporting pain after falling which caused a periprosthetic fracture.The surgeon revised the stem, head, and liner.The surgery was completed successfully.On (b)(6) 2024, the patient came in reporting pain due to a subsided stem.The surgeon revised the stem, head and liner.The surgery was completed successfully.The surgeon thinks that the stem was undersized for the patient.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: DISTAL STEM Ø13MM
• 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: 20724173
• Report Number: 3005180920-2024-00952
• Device Sequence Number: 3850884
• Product Code: LZO
• UDI-Device Identifier: 07630030884993
• UDI-Public: 07630030884993
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/19/2024

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: 01.22.102
• Device Lot Number: 2336074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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 Age: 64 YR
• Patient Sex: Female