MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS COLLARED SOLID STEM LAT SIZE3

Model Number	01.36.163
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At approximately 4 months after the primary procedure, the patient presented to the hospital complaining of pain and periprosthetic fracture was confirmed.The surgeon commented that the patient`s large body size may have contributed to the issue.Cable fixation performed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 february 2026.Lot 2409959: 20 items manufactured and released on 11-sep-2024.Expiration date: 2029-08-26.No anomalies found related to the problem.To date, 8 items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation.Periprosthetic femoral fracture shortly after primary cementless tha.It is very likely that the femur may have been damaged during preparation at index surgery: it is one possible adverse event, described in the instructions for use and rather recurring in literature.The patient is reported to be of high body weight: while weight itself is not a problem for the implants, a large body mass may make surgery more difficult, and the high retraction force that must be applied to the soft tissues may carry additional stresses to the bone during surgery.No reason to suspect a faulty device as the cause of this adverse event.Root cause:based on the information available, no definitive root cause can be established, although patient-related biomechanical factors may have contributed.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 COLLARED SOLID STEM LAT SIZE3
• 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: 24518512
• Report Number: 3005180920-2026-00117
• Device Sequence Number: 21263557
• Product Code: LZO
• UDI-Device Identifier: 07630345701855
• UDI-Public: 07630345701855
• Combination Product (Y/N): N
• PMA/510(K) Number: K203041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 01.36.163
• Device Lot Number: 2409959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2024
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian