MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS COLLARED SOLID STEM STD SIZE7

Model Number	01.36.147
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came had pain and instability due to a loose stem and the cause is unknown.There was no indication towards trauma or a fall.At about 11 months post primary the surgeon revised the medacta d 36 mpact liner to a medacta d 40 mpact liner, and revised the medacta head and stem to a competitor head and stem.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: 1 year after primary cementless tha the stem is mobilized and needs revision.The one radiograph supplied shows a stem in a valgus position, which may have given a deceptive sensation of stability in spite of the undersizing.Yet, the radiograph may have a poor rotation of the treated leg, which could cause a wrong interpretation.No reason to suspect a faulty device.Batch review performed on 23 february 2026: lot 2405726: (b)(4) manufactured and released on 04-jul-2024.Expiration date: 2029-jun-17.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Root cause: aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: SMS STEM
• Common Device Name: SMS COLLARED SOLID STEM STD SIZE7
• 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: 24588554
• Report Number: 3005180920-2026-00193
• Device Sequence Number: 9485637
• Product Code: LZO
• UDI-Device Identifier: 07630345701749
• UDI-Public: 07630345701749
• 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): 03/13/2026

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: 01.36.147
• Device Lot Number: 2405726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2024
• 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 Sex: Male