MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN LT SZ 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka on (b)(6) 2017, the patient experienced left knee pain.This adverse event resulted in a revision surgery where a journey ii bcs femoral oxinium left size 8 (case (b)(4)) and a jrny ii bcs xlpe art isrt sz 7-8 lt 11mm (case (b)(4)) were explanted.This was treated on (b)(6) 2021.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a revision was performed due to left knee pain almost 4 years post implantation.It was communicated that the requested clinical documentation would not be provided for inclusion in the medical investigation and the explants were not available for evaluation.Without the requested medical documentation, the clinical root cause of the reported event could not be fully evaluated and could not be definitively concluded the patient impact beyond the reported pain and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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.We consider this investigation closed.

• Brand Name: JRNY II BCS FEMORAL OXIN LT SZ 8
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12076660
• Report Number: 1020279-2021-05468
• Device Sequence Number: 11809086
• Product Code: JWH
• UDI-Device Identifier: 00885556170564
• UDI-Public: 00885556170564
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74022128
• Device Catalogue Number: 74022128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention