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

Model Number 02.18.004RM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 january 2021: lot 167877: (b)(4) items manufactured and released on 21-feb-2017.Expiration date: 2022-02-08.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since 1-1-2017.Another implants involved: batch review performed on 25 january 2021: moto partial knee 02.18.Tf5.Rm tibial tray fix cemented s5 rm (k162084)lot.160695: (b)(4) items manufactured and released on 21-oct-2016.Expiration date: 2021-05-26.No anomalies found related to the problem.To date, al the items of the same lot have been already sold without any similar reported event since 1-1-2017.Batch review performed on 25 january 2021: moto partial knee 02.18.If5.08.Rm tibial insert fix s5 rm - 8mm (k162084)lot.161214: (b)(4) items manufactured and released on 24-oct-2016.Expiration date: 2021-06-01.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 since 1-1-2017.

Event Description

The patient came in reporting pain and instability and the cause of the pain and instability was due to ligaments that had loosened over time.3 years and 3 months after primary the surgeon revised the femoral component, insert, and tibial tray.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM
• Type of Device: KNEE FEMORAL CEMENTED PROSTHESIS
• 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: 11307550
• MDR Text Key: 231154754
• Report Number: 3005180920-2021-00105
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895609
• UDI-Public: 07630030895609
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/10/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2022
• Device Model Number: 02.18.004RM
• Device Catalogue Number: 02.18.004RM
• Device Lot Number: 167877
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2017
• 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