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
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: KNEE FEMORAL CEMENTED PROSTHESIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11307550
• Report Number: 3005180920-2021-00105
• Device Sequence Number: 11606566
• Product Code: HSX
• UDI-Device Identifier: 07630030895609
• UDI-Public: 07630030895609
• 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: 2017
• Device Explanted Year: 2021
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/10/2021
• 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