MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS STEM; SMS SOLID STEM STD SIZE 12

Model Number	01.36.052
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2025.Lot 2108219: (b)(4) items manufactured and released on 27-oct-2021.Expiration date: 2026-10-14.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.Additional items involved in the complaint, batch review performed on 28 may 2025.Ball heads: mectacer 01.29.234h mectacer head biolox option 12/14 ø 44 (k131518) lot.2433586 lot 2433586: (b)(4) items manufactured and released on 16-dec-2024.Expiration date: 2029-11-28.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.Cup: mpact 3d metal monocer 01.42.054mcc acetabular shell ø54/44 lot.2422834 (item not registered in us) lot 2422834: (b)(4) items manufactured and released on 05-nov-2024.Expiration date: 2029-09-19.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: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
Revision surgery performed at about 2 months after the primay following infection.

• Brand Name: SMS STEM
• Common Device Name: SMS SOLID STEM STD SIZE 12
• 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: 22193039
• Report Number: 3005180920-2025-00552
• Device Sequence Number: 9227920
• Product Code: LZO
• UDI-Device Identifier: 07630030888717
• UDI-Public: 07630030888717
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181693
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: 01.36.052
• Device Lot Number: 2108219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2021
• 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 Age: 58 YR
• Patient Sex: Male