MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM; PARTIAL KNEE CEMENTED ANATOMICAL FEMORAL COMPONENT

Catalog Number	02.18.005RM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2023 lot 2105461: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-05-05.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Additional involved implants.Batch review performed on 13 december 2023 on moto partial knee 02.18.If6.08.Rm tibial insert fix s6 rm - 8mm (k162084) lot.2005390 lot 2005390: (b)(4) items manufactured and released on 29-july-2020.Expiration date: 2025-07-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 13 december 2023 on moto partial knee 02.18.Tf6.Rm tibial tray fix cemented s6 rm (k162084) lot.2009944 lot 2009944: (b)(4) items manufactured and released on 23-dec-2020.Expiration date: 2025-12-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At 1 year 7 months after the primary, the patient came in reporting pain due to inflammation.The surgeon revised the moto partial knee to a total knee and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM
• Common Device Name: PARTIAL KNEE CEMENTED ANATOMICAL FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18372065
• Report Number: 3005180920-2023-01038
• Device Sequence Number: 7710785
• Product Code: HSX
• UDI-Device Identifier: 07630030895623
• UDI-Public: 07630030895623
• 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: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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: 05/05/2026
• Device Catalogue Number: 02.18.005RM
• Device Lot Number: 2105461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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: Female