MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM; KNEE FEMUR IMPLANT

Model Number	02.18.004RM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised all implants, performed a washout and implanted a total semi-costained system.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 january 2022: lot 2007537: (b)(4) items manufactured and released on 09-oct-2020.Expiration date: 2025-09-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional devices involved: batch reviews performed on 11 january 2022: moto partial knee 02.18.Tf5.Rm tibial tray fix cemented s5 rm (k162084) lot 2009942: (b)(4) items manufactured and released on 22-dec-2020.Expiration date: 2025-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Moto partial knee 02.18.If5.08.Rm tibial insert fix s5 rm - 8mm (k162084) lot 2009911: (b)(4) items manufactured and released on 17-nov-2020.Expiration date: 2025-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM
• Common Device Name: KNEE FEMUR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13415523
• Report Number: 3005180920-2022-00057
• Device Sequence Number: 17115253
• Product Code: JWH
• UDI-Device Identifier: 07630030895609
• UDI-Public: 07630030895609
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/01/2022

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: 09/28/2025
• Device Model Number: 02.18.004RM
• Device Catalogue Number: 02.18.004RM
• Device Lot Number: 2007537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2020
• 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 Sex: Unknown