MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.003RM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM; KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED

Catalog Number 02.18.003RM

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16-feb-2024.Lot 189249: (b)(4) items manufactured and released on 13-mar-2019.Expiration date: 2024-03-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review additional components involved in the event: moto partial knee 02.18.Tf4.Rm tibial tray fix cemented s4 rm (k162084) lot 1904728: (b)(4) items manufactured and released on 18-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 with no similar reported case during the period of the review.Moto partial knee 02.18.If4.08.Rm tibial insert fix s4 rm - 8mm (k162084) lot 1903777: (b)(4) items manufactured and released on 24-jul-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 with another similar reported case during the period of review.

Event Description

At about 4 years and 2 months after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted new permanent hardware.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE 02.18.003RM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM
• Type of Device: KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED
• 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: 18892568
• MDR Text Key: 337510309
• Report Number: 3005180920-2024-00097
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895586
• UDI-Public: 07630030895586
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Catalogue Number: 02.18.003RM
• Device Lot Number: 189249
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2019
• 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
• Patient Sex: Female