MAUDE Adverse Event Report: Medacta International SA SMS Stem; SMS Solid Stem STD size8

Model Number	01.36.048
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Implant Pain (4561)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in presenting pain due to a fracture and subsided stem and the cause is unknown.About 2 years and 9 months after the primary surgery, the surgeon revised the stem and head.Patient`s bone quality good (65 years old), the fracture was already healed at the time of the revision.M-vizion stem implanted.
Additional Manufacturer Narrative
Clinical evaluation approximately 2 years and 9 months after primary cementless tha, revision surgery was performed because of pain associated with femoral fracture and stem subsidence.No traumatic event was reported and bone quality was described as good.The available ap radiograph is of limited quality; nevertheless, the femoral stem appears relatively undersized, with no convincing radiographic signs of osseointegration, and its position is compatible with loss of fixation and subsidence.The relationship between the fracture and stem mobilization cannot be established with certainty.It is possible that insufficient initial fixation and subsequent failure of osseointegration led to progressive stem instability, with the fracture occurring secondarily; alternatively, the fracture itself may have contributed to loss of fixation.The fracture does not have an obviously pathological appearance, although this cannot be excluded without further clinical and radiographic history.It is also unclear how the patient evolved during the almost three years following implantation.Based on the available information, there are no elements to suggest a defective or malfunctioning device.Batch review performed on 31 august 2026 lot 2246305: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 26-mar-2028.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: the event may be related to insufficient initial stem fixation and subsequent failure of osseointegration, leading to progressive instability and subsidence, although it cannot be determined whether the femoral fracture was a cause or a consequence of the loss of fixation.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.

• Brand Name: SMS Stem
• Common Device Name: SMS Solid Stem STD size8
• 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: 50784460
• Report Number: 3005180920-2026-00943
• Device Sequence Number: 18495743
• Product Code: LZO
• UDI-Device Identifier: 07630030888670
• UDI-Public: 07630030888670
• Combination Product (Y/N): N
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 01.36.048
• Device Lot Number: 2246305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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: 65 YR
• Patient Sex: Unknown