MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 RM - 8MM

Model Number	02.18.IF2.09.RM
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 167782: (b)(4) items manufactured and released on 17-jan-2017.Expiration date: 2021-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional devices involved batch reviews performed on (b)(6) 2020: moto partial knee 02.18.002rm anatomical femoral component cemented s2 rm (k162084) lot 173332: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 2022-09-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Moto partial knee 02.18.Tf2.Rm tibial tray fix cemented s2 rm (k162084) lot 170790: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 2 years and 4 months after primary surgery, due to signs of infection and the pathogen is escherichia coli.The surgeon performed a washout, removed all components, and implanted a femoral component and insert with antibiotic cement to act as a spacer.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 RM - 8MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10776752
• Report Number: 3005180920-2020-00772
• Device Sequence Number: 17087053
• Product Code: HSX
• UDI-Device Identifier: 07630030895883
• UDI-Public: 07630030895883
• 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: 2018
• Device Explanted Year: 2020
• 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): 11/03/2020

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: 12/13/2021
• Device Model Number: 02.18.IF2.09.RM
• Device Catalogue Number: 02.18.IF2.09.RM
• Device Lot Number: 167782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention