MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS COLLARED SOLID STEM LAT SIZE 5

Model Number	01.36.165
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year from primary, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised stem, head, and liner and also implanted a dm coverter.Surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17-jun-2025: lot 2211325: (b)(4) items manufactured and released on 18-10-2022 expiration date: 2027-10-03.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.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 LAT SIZE 5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22402969
• Report Number: 3005180920-2025-00620
• Device Sequence Number: 8293831
• Product Code: LZO
• UDI-Device Identifier: 07630345701879
• UDI-Public: 07630345701879
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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: 01.36.165
• Device Lot Number: 2211325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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