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

Catalog Number UNKN01200300

Device Problem Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 06/23/2021

Event Type  Injury  

Event Description

It was reported that, after knee arthroplasty had been performed, the patient experienced complications.This adverse event was treated by performing a revision surgery on (b)(6) 2021.The patient's soft tissue presented signs of metallosis due to an unknown journey i broken peg that was rubbing against titanium baseplate.The device was replaced with an unknown journey ii.Surgery was completed successfully and the patient's knee was well balanced.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the broken peg was confirmed.The clinical/medical investigation concluded that, the two x-rays provided revealed do not contribute to the root cause.Although it was reported the soft tissue had signs of metallosis, without the requested supporting lab/pathology results, imaging, and/or the analysis of the explanted components the reported metallosis cannot be confirmed.Nor can it be concluded that the reported clinical symptoms were associated with a mal performance of the implant.It is the end user¿s responsibility to maintain adequate supply of the journey i and understand component availability prior to procedures.Based on the information provided, the surgeon chose the off-label use of the journey ii poly on a journey i femur.Per report, the surgery was successfully completed with an unknown journey ii and the patient¿s knee was well balanced.The impact to the patient beyond that which has already been reported cannot be determined.Therefore, no further clinical/medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, user error, damaged product, implant corrosion or wear.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: UNKN JOURNEY KNEE IMPL
• 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: 12125702
• MDR Text Key: 260218371
• Report Number: 1020279-2021-05771
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention