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

Catalog Number 02.18.002RM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 01/31/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 335985560
• Report Number: 3005180920-2024-00070
• Device Sequence Number: 1
• Product Code: HSX
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.002RM
• Device Lot Number: 2215085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2022
• 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