MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74025622

Device Problems Degraded (1153); Biocompatibility (2886); Deformation Due to Compressive Stress (2889)

Patient Problem Metal Related Pathology (4530)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after primary surgery was performed on (b)(6) 2022, there were no problems 3 months postoperatively.On (b)(6) 2024, there was sign of infection, and x-rays showed abnormal soft tissue growth and metallosis.All implants were removed on (b)(6) 2024.The jrny ii cr isrt xlpe lt sz 1-2 10mm was worn and deformed.The jrny ii cr fem ox np lt sz 3 and journey tibia base np lt sz 2 were also significantly worn due to hit each other.Heath status of the patient is unknown.

• Brand Name: JRNY II CR ISRT XLPE LT SZ 1-2 10MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18842337
• MDR Text Key: 336956511
• Report Number: 1020279-2024-00494
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556422663
• UDI-Public: 00885556422663
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74025622
• Device Lot Number: 20JM02881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Date Device Manufactured: 09/03/2020
• 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
• Treatment: JOURNEY TIBIA BASE NP LT SZ 2, LOT#:22CM18432; JRNY II CR FEM OX NP LT SZ 3, LOT#:21AM03731
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female