MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY BCS / JOURNEY II BCS KNEE FEM COMP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200303

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

Patient Problems Unspecified Infection (1930); Joint Laxity (4526); Implant Pain (4561)

Event Date 06/01/2021

Event Type  Injury  

Event Description

It was reported that, after knee replacement surgery with a journey ii bcs system had been performed on (b)(6) 2018, the patient experienced pain, loosening and an infection.This adverse event was treated by a revision surgery on (b)(6) 2021.All four components, insert, femur, tibia, and patella, were explanted.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested clinical information, the implantation/revision reports, lab findings, radiographs or the device, the clinical root cause of the reported pain, loosening and an infection cannot be determined.Although it was reported this adverse with was treated with a revision with the removal of the insert, femur, tibia, and patella.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, post-operative healing issue, abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, joint tightness, material in use, patient reaction and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Additional information: d3.

• Brand Name: UNKN JOURNEY BCS / JOURNEY II BCS KNEE FEM COMP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12059860
• MDR Text Key: 258119877
• Report Number: 1020279-2021-05429
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75