MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 LM

Model Number	02.18.005LM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 months and a half after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the femur and poly.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 21 march 2022.Lot 2105460: 48 items manufactured and released on 26-may-2021.Expiration date: 2026-05-09.No anomalies found related to the problem.To date, 30 items of the same lot have been sold without any similar reported event.Additional item involved in the event, batch review performed on 21 march 2022.Moto partial knee 02.18.If6.08.Lm tibial insert fix s6 lm - 8mm (k162084) lot.2009914 lot 2009914: 20 items manufactured and released on 25-nov-2020.Expiration date: 2025-11-04.No anomalies found related to the problem.To date, 6 items of the same lot have been sold without any similar reported event.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 LM
• Common Device Name: PARTIAL KNEE ANATOMICAL FEMORAL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 14014699
• Report Number: 3005180920-2022-00237
• Device Sequence Number: 12334239
• Product Code: HSX
• UDI-Device Identifier: 07630030895616
• UDI-Public: 07630030895616
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 05/09/2026
• Device Model Number: 02.18.005LM
• Device Catalogue Number: 02.18.005LM
• Device Lot Number: 2105460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• 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 Sex: Male