MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS COLLARED SOLID STEM STD SIZE4

Model Number	01.36.144
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At approximately 2 years and 8 months after the primary surgery, the patient experienced implant loosening.No further information has been received.
Additional Manufacturer Narrative
Batch review performed on 11 may 2026 lot 2218146: (b)(4) items manufactured and released on 05 january 2023.Expiration date: 07 december 2027.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.Lot 2005100: (b)(4) items manufactured and released on 11 september 2020.Expiration date: 02 september 2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.Root cause: aseptic loosening is a possible literature-described adverse event after primary hip 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 SIZE4
• 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: 25275479
• Report Number: 3005180920-2026-00481
• Device Sequence Number: 13201228
• Product Code: LZO
• UDI-Device Identifier: 07630345701718
• UDI-Public: 07630345701718
• Combination Product (Y/N): N
• PMA/510(K) Number: K203041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/26/2026

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: 01.36.144
• Device Lot Number: 2218146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female