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

Model Number 02.18.006RM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/14/2020

Event Type  Injury  

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 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
• Type of Device: PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED
• 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: 9698646
• MDR Text Key: 178756419
• Report Number: 3005180920-2020-00041
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895647
• UDI-Public: 07630030895647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR