MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION DISTAL STEM Ø13MM L 140MM STRAIGHT; HIP FEMUR DISTAL STEM

Catalog Number	01.22.102
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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).
Additional Manufacturer Narrative
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.

• Brand Name: STEM: M-VIZION DISTAL STEM Ø13MM L 140MM STRAIGHT
• Common Device Name: HIP FEMUR DISTAL STEM
• 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: 19826342
• Report Number: 3005180920-2024-00541
• Device Sequence Number: 8665765
• Product Code: LZO
• UDI-Device Identifier: 07630030884993
• UDI-Public: 07630030884993
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170690
• 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): 07/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.22.102
• Device Lot Number: 2115443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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: Female