MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS SOLID STEM STD SIZE5

Model Number	01.36.045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to a periprosthetic fracture after about 2 years and 2 months from primary surgery.The surgeon cabled the fracture and revised the medacta head and stem to a competitor head and stem.The surgeon also revised the d 36/e hooded pe hc liner to a d 36/e flat pe hc liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01 july 2026: lot 2248974: (b)(4) items manufactured and released on 19-apr-2023.Expiration date: 2028-mar-29.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.The available clinical information does not indicate trauma and the relevant x-rays were not available for review.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 potentially related manufacturing issue.

• Brand Name: SMS STEM
• Common Device Name: SMS SOLID STEM STD SIZE5
• 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: 25747725
• Report Number: 3005180920-2026-00657
• Device Sequence Number: 10086474
• Product Code: LZO
• UDI-Device Identifier: 07630030888649
• UDI-Public: 07630030888649
• Combination Product (Y/N): N
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/08/2026

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: 01.36.045
• Device Lot Number: 2248974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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 Sex: Unknown