MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS SOLID STEM STD SIZE 3

Catalog Number	01.36.043
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 5 months from the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem and head and surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 march 2024 lot 1902970: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-06-25.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.
Additional Manufacturer Narrative
Batch review performed on 04 march 2025.Lot: 2218128: (b)(4) items manufactured and released on 17-jan-2023.Expiration date: 2027-12-27.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.Correction: on (b)(6) 2025, a complaint related to a second revision due to the stem mobilization of the same patient as this complaint was reported.The listed stem was the same in both complaints.After investigation, it was found that the stem previously reported in this complaint was the one implanted and not revised.All the mdr fields have been modified accordingly.Primary surgery on (b)(6) 2023, ref.(b)(4), lot.2218128 implanted.1st revision surgery on (b)(6) 2024, ref.(b)(4), lot: 2218128 explanted, ref.(b)(4), lot: 1902970, implanted.2nd revision surgery on (b)(6) 2025, ref.(b)(4), lot: 1902970 explanted (mdr: (b)(4).
Event or Problem Description
At 5 months from the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem and head and surgery was completed successfully.

• Brand Name: SMS STEM
• Common Device Name: SMS SOLID STEM STD SIZE 3
• 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: 19069662
• Report Number: 3005180920-2024-00190
• Device Sequence Number: 17867597
• Product Code: LZO
• UDI-Device Identifier: 07630030888625
• UDI-Public: 07630030888625
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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 Catalogue Number: 01.36.043
• Device Lot Number: 2218128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• 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: Male