MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION FEMORAL REVISION SYSTEM; STEM: M-VIZION DISTAL STEM Ø16MM L 220MM STRAIGHT

Model Number	01.22.165
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); 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 29-oct-2024: lot 2200650: (b)(4) items manufactured and released on 08-jun-2022.Expiration date: 2027-05-17.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 medical affairs department: a revision surgery was performed one month after implantation of an m-vizion stem during a total hip arthroplasty (tha).The patient reported pain, and the available x-ray images reveal a dislocation of the prosthetic hip.Additionally, the femur shape appears irregular, with cerclage wires along the length of the stem, and the stem likely shows signs of subsidence.Details about the initial surgery are unavailable (e.G., fracture or osteotomy), but it is possible that in such a complex case, the femoral stem did not achieve adequate primary stability, leading to subsequent subsidence.The observed dislocation may have occurred as a consequence of this subsidence.We see no reason to suspect a defective device.Additional component involved and revised: stem: m-vizion 01.22.405 proximal body ø20mm l 80mm std with holes (k201471) lot 2010778: (b)(4) items manufactured and released on 27-oct-2021.Expiration date: 2026-10-12.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.Ball heads: mectacer 01.29.205 mectacer head biolox delta dia.32 12/14-m (k112115) lot 2338625: (b)(4) items manufactured and released on 11-oct-2023.Expiration date: 2028-09-25.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: based on the information available no definitive root cause can be established because it is not possible to retrieve other information.From the x-rays analysis, it is likely that the joint luxation and stem subsidence contributed to the reported issue.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 surgery with a competitor on an unknown date.Subsequently, on the (b)(6) 2024, the competitor stem and head were revised to medacta implants.Presently, on (b)(6) 2024, the patient came in reporting pain and the cause is unknown.The surgeon revised the medacta stem and head with competitor implants.Surgery was completed successfully.No issues detected with implants, only pain was reported.It is unknown whether or not the competitor liner was revised, but a medacta liner was not used in any surgery.The district sales manager didn't have any reps in this hospital area so no other information is available.From the analysis of the x-rays, it is visible that joint luxation occurred.Moreover, the femur shape appears irregular, with cerclage wires and the stem likely shows signs of subsidence, probably a result of non-adequate primary stability.

• Brand Name: M-VIZION FEMORAL REVISION SYSTEM
• Common Device Name: STEM: M-VIZION DISTAL STEM Ø16MM L 220MM STRAIGHT
• 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: 20734636
• Report Number: 3005180920-2024-00956
• Device Sequence Number: 12923753
• Product Code: LZO
• UDI-Device Identifier: 07630040729116
• UDI-Public: 07630040729116
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K191816
• 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): 11/20/2024

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: 01.22.165
• Device Lot Number: 2200650
• 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: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2022
• 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: Unknown