MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; KNEE ANATOMICAL CEMENTED FEMORAL COMPONENT

Model Number	02.18.002RM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 jan 2025 lot 2008201: (b)(4) items manufactured and released on 21-oct-2020.Expiration date: 2025-oct-08.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional implant revised.Batch review performed on 2 jan 2025 on moto partial knee 02.18.Tf4.Rm tibial tray fix cemented s4 rm (k162084) lot.2004985.Lot 2004985: (b)(4) items manufactured and released on 02-sep-2020.Expiration date: 2025-aug-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.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.
Event or Problem Description
The patient came in reporting pain due to femoral and tibial components mobilized.About 4 years after the primary surgery, the surgeon revised all components to revision components (augments used on the distal and posterior femur due to bone loss.A primary would not have been sufficient.).The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: KNEE ANATOMICAL CEMENTED FEMORAL COMPONENT
• 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: 21207093
• Report Number: 3005180920-2024-01174
• Device Sequence Number: 14438926
• Product Code: HSX
• UDI-Device Identifier: 07630030895562
• UDI-Public: 07630030895562
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 01/22/2025

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 Expiration Date: 10/08/2025
• Device Model Number: 02.18.002RM
• Device Lot Number: 2008201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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: 60 YR
• Patient Sex: Female