MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; LOCKING SCREW

Model Number	01.22.201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The locking screw was found to be fractured during the revision surgery, making removal of the proximal body from the distal body impossible.An attempt to explant the entire stem was unsuccessful.Consequently, the surgeon decided to leave the stem in situ and replace only the femoral head with a competitor component.The surgery was prolonged by about 30 minutes.It is suspected that the locking screw broke when implanted during the primary procedure.The revision surgery was performed about 4 years after the primary surgery due to pain and malrotation of the stem.The surgeon wanted to revise the m-vizion proximal body to correct the implant angle.
Additional Manufacturer Narrative
The visual inspection will be performed.
Additional Manufacturer Narrative
Fu1 device returned on 02 march 2026 r&d project manager analysis: the screw was found broken intraoperatively, during a revision of the m-vizion proximal body due to malrotation.Only the upper portion of the screw is available for inspection, while the lower portion remained in situ.The screw fracture occurred at the first thread.Some material at the start of the first thread is missing.The bottom surface of the screw showed evidence of scratching, suggesting contact with the bottom of the proximal body hole.Coating loss due to scratching is visible on the screw head, which may have resulted from contact with the proximal body during the removal of the component.No additional parts are available for inspection.The exact root cause of the screw breakage could not be definitively determined.It is suspected that an assembly-related condition in the primary surgery may have contributed to the breakage.Root cause: although a precise root cause cannot be established, the screw fracture is likely related to a possible assembly-related condition during the primary surgery, potentially in combination with intraoperative factors.The manufacturing history review could not be performed as the lot number of the locking screw is unknown.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24494911
• Report Number: 3005180920-2026-00130
• Device Sequence Number: 5092090
• Product Code: LZO
• UDI-Device Identifier: 07630030885143
• UDI-Public: 07630030885143
• Combination Product (Y/N): N
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 01.22.201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White