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

Catalog Number 02.18.004RM

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

Patient Problem Implant Pain (4561)

Event Date 07/27/2023

Event Type  Injury  

Event Description

The patient came in reporting discomfort and pain and the reason is unknown.About 1 year and 6 months, the surgeon revised the patient from a moto knee to a total knee.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 3 august 2023.Lot 2103522: (b)(4) items manufactured and released on 08-apr-2021.Expiration date: 2026-mar-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional implants involved, batch review performed on 3 august 2023: moto partial knee 02.18.If4.09.Rm tibial insert fix s4 rm - 9mm (k162084) lot 2103537: (b)(4) items manufactured and released on 05-may-2021.Expiration date: 2026-apr-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Moto partial knee 02.18.Tf4.Rm tibial tray fix cemented s4 rm (k162084) lot 2105880: (b)(4) items manufactured and released on 02-aug-2021.Expiration date: 2026-jul-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 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: 17497350
• MDR Text Key: 320764240
• Report Number: 3005180920-2023-00649
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895609
• UDI-Public: 07630030895609
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.004RM
• Device Lot Number: 2103522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2021
• 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