MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.004RM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM

Model Number	02.18.004RM
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 february 2022: lot 1908022: (b)(4) items manufactured and released on 15-nov-2019.Expiration date: 2024-11-05.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event.Other devices involved: batch review performed on 02 february 2022: moto partial knee 02.18.Tf5.Rm tibial tray fix cemented s5 rm (k162084) lot 1903771: (b)(4) items manufactured and released on 17-oct-2019.Expiration date: 2024-10-07.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event.Moto partial knee 02.18.If5.08.Rm tibial insert fix s5 rm - 8mm (k162084) lot 1903779: (b)(4) items manufactured and released on 24-july-2019.Expiration date: 2024-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain due to a torn meniscus on the lateral side and the cause is unknown.At 1 year and 7 months from the primary the surgeon revised the insert, tibial tray, and femoral component.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 february 2022: lot 1908022: (b)(4) items manufactured and released on 15-nov-2019.Expiration date: 2024-11-05.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event.Other devices involved: batch review performed on 02 february 2022: moto partial knee 02.18.Tf5.Rm tibial tray fix cemented s5 rm (k162084) lot 1903771: (b)(4) items manufactured and released on 17-oct-2019.Expiration date: 2024-10-07.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event.Moto partial knee 02.18.If5.08.Rm tibial insert fix s5 rm - 8mm (k162084) lot 1903779: (b)(4) items manufactured and released on 24-july-2019.Expiration date: 2024-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain due to a torn meniscus on the lateral side and the cause is unknown.At 1 year and 7 months from the primary the surgeon revised the insert, tibial tray, and femoral component.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE 02.18.004RM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM
• Common Device Name: 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: 13567347
• Report Number: 3005180920-2022-00139
• Device Sequence Number: 12224497
• 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: 2020
• Device Explanted Year: 2022
• 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): 02/21/2022

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: 11/05/2024
• Device Model Number: 02.18.004RM
• Device Catalogue Number: 02.18.004RM
• Device Lot Number: 1908022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male