MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM

Model Number	02.18.006RM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22.01.2020: lot 167879: (b)(4) items manufactured and released on 15.02.2017.Expiration date: 2022-02-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Other devices involved in the event.Moto partial knee 02.18.Tf5.Rm tibial tray fix cemented s5 rm lot.167759 (k162084).Batch review performed on 22.01.2020: lot 167759: (b)(4) items manufactured and released on 21.02.2017.Expiration date: 2022-02-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Moto partial knee 02.18.If5.08.Rm tibial insert fix s5 rm 8mm lot.167817 (k162084).Batch review performed on 22.01.2020: lot 167817: (b)(4) items manufactured and released on 03.01.2017.Expiration date: 2021-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event since 2016.
Event or Problem Description
Revision surgery performed 9 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon removed the femoral component, tibial tray, and insert and implanted a femur, patella and liner.The surgeon will wait for the infection to clear before implanting permanent hardware.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM
• Common Device Name: PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9698646
• Report Number: 3005180920-2020-00041
• Device Sequence Number: 14159271
• Product Code: HSX
• UDI-Device Identifier: 07630030895647
• UDI-Public: 07630030895647
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 02/06/2022
• Device Model Number: 02.18.006RM
• Device Catalogue Number: 02.18.006RM
• Device Lot Number: 167879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/12/2020
• 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
• Patient Age: 75 YR