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

Model Number	02.18.004RM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26.Feb.2021: lot 2004506: (b)(4) items manufactured and released on 10-lug-2020.Expiration date: 2025-07-03.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.Additional devices involved batch reviews performed on 26.Feb.2021: moto partial knee 02.18.If3.09.Rm tibial insert fix s3 rm - 9mm (k162084) lot 168055: (b)(4) items manufactured and released on 9-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 other similar reported event.Moto partial knee 02.18.Tf3.Rm tibial tray fix cemented s3 rm (k162084) lot 1910822: (b)(4) items manufactured and released on 26-mar-2020.Expiration date: 2025-03-20.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.
Event or Problem Description
The patient came in 3 months after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon removed all components and implanted medacta femur and insert with antibiotic cement to act as a spacer.The surgery was completed successfully.
Event or Problem Description
The patient came in 3months after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon removed all components and implanted medacta femur and insert with antibiotic cement to act as a spacer.The surgery was completed successfully.This patient came in and had the spacer removed and permanent hardware implanted on (b)(6) 2021.
Additional Manufacturer Narrative
On april 07th 2021 we have received the following information: this patient came in and had the spacer removed and permanent hardware implanted on (b)(6) 2021.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11493347
• Report Number: 3005180920-2021-00208
• Device Sequence Number: 14789598
• Product Code: HSX
• UDI-Device Identifier: 07630030895609
• UDI-Public: 07630030895609
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 07/03/2025
• Device Model Number: 02.18.004RM
• Device Catalogue Number: 02.18.004RM
• Device Lot Number: 2004506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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: 49 YR
• Patient Weight: 90