MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS SOLID STEM LAT SIZE10

Model Number	01.36.070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: few days after primary cementless tha, a proximal femoral fracture occurs.The stem is exchanged to a longer one, and the fracture is cabled.No problems removing the stem, as was to be expected given the very short time after index surgery.The femoral resection is particularly high, the surgeon probably wanted to preserve the natural femoral neck.The stem was apparently well positioned; we do not agree with the statement in the report that it may have been excessively varus.However, the high resection may have induced the surgeon to apply particular force to achieve good primary stability, and this may have weakened the bone, which failed once rehabilitation loads were applied.No reason to suspect a faulty device.Batch review performed on 04 february 2026: lot: 2214064: (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 2027-nov-28.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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery about 2 weeks post op due to femur bone fracture.Stem and head revised successfully.The surgeon reported that the fracture is likely due to a poor bone quality of the patient associated with a varus morphology of the femur.

• Brand Name: SMS STEM
• Common Device Name: SMS SOLID STEM LAT SIZE10
• 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: 24429840
• Report Number: 3005180920-2026-00119
• Device Sequence Number: 10297507
• Product Code: LZO
• UDI-Device Identifier: 07630030888823
• UDI-Public: 07630030888823
• Combination Product (Y/N): N
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 02/24/2026

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: 01.36.070
• Device Lot Number: 2214064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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: Male