MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 RM; KNEE FEMORAL COMPONENT

Catalog Number	02.18.002RM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06-feb-2024 lot 2215085: 18 items manufactured and released on 27-sep-2022.Expiration date: 2027-09-11.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported case during the period of review.Additional implants involved, batch review performed on 06-feb-2024: moto partial knee 02.18.If2.08.Rm tibial insert fix s2 rm - 8mm (k162084) lot 2218371: 32 items manufactured and released on 10-oct-2022.Expiration date: 2027-09-21.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with no similar reported case during the period of review.Moto partial knee 02.18.Tf2.Rm tibial tray fix cemented s2 rm (k162084) lot 2211033: 10 items manufactured and released on 31-aug-2022.Expiration date: 2027-08-18.No anomalies found related to the problem.To date, 9 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 1 year after primary, the patient came in reporting pain and the cause is unknown.The surgeon revised moto partial knee system to a gmk-sphere system.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 RM
• Common Device Name: KNEE 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: 18756833
• Report Number: 3005180920-2024-00070
• Device Sequence Number: 15037321
• Product Code: HSX
• UDI-Device Identifier: 07630030895562
• UDI-Public: 07630030895562
• 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: 2023
• Device Explanted Year: 2024
• 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): 02/22/2024

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 Catalogue Number: 02.18.002RM
• Device Lot Number: 2215085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2022
• 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: Unknown