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

Model Number	01.36.167
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at 8 months after the primary due to stem loosening.The surgeon revised the sms collared solid stem size 7 to an m-finity collared stem size 10.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16 mar 2026.Lot 2339808: (b)(4) items manufactured and released on 26-feb-2024.Expiration date: 2029-feb-07.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 device history record review does not indicate any potential manufacturing related issue.

• Brand Name: SMS STEM
• Common Device Name: SMS COLLARED SOLID STEM LAT 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: 24762673
• Report Number: 3005180920-2026-00298
• Device Sequence Number: 10276536
• Product Code: LZO
• UDI-Device Identifier: 07630345701893
• UDI-Public: 07630345701893
• 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): 04/02/2026

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: 01.36.167
• Device Lot Number: 2339808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2024
• 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: Unknown