MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP INSTRUMENTS; M-VIZION PROXIMAL BODY HANDLE

Model Number	01.22.10.0151
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 may 2025: lot 2479883: (b)(4) items manufactured and released on 18-feb-2025.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Visual inspection performed by r&d department the proximal body handle shows a visible warping due to an excessive torque applied.The proximal body handle is used to disassembly the modular connection of the implant and, in random situations, the force required is higher than the instrument mechanical resistance of the instrument.Additional involved devices: (b)(6) disassembly rod lot.2155067 batch review performed on (b)(6) 2025: (b)(4) items manufactured and released on 03-nov-2021.No anomalies found related to the problem.To date, one similar events have been reported on the same lot during the period of review.
Event or Problem Description
After proximal body insertion, the surgeon wasn't happy with the stem version and wanted to change it.The proximal body handle was screwed on the neck and the small rod placed inside with the t-handle.But it was impossible to remove the proximal body because the handle was starting to bend.The surgeon changed the cup to a dual mobility to compensate for the version.

• Brand Name: HIP INSTRUMENTS
• Common Device Name: M-VIZION PROXIMAL BODY HANDLE
• 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: 22149349
• Report Number: 3005180920-2025-00539
• Device Sequence Number: 7849255
• Product Code: LXH
• UDI-Device Identifier: 07630040739252
• UDI-Public: 07630040739252
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.22.10.0151
• Device Lot Number: 2479883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male