MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 7; PROSTHESISKNEPATELOFMOROTIBIALSEMICONSTRAINDCMNTDPOLYMRMETALPOLYMER

Model Number	74022127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presents patellofemoral pain.Low patellar tilt and lateralization of patella.A procedure was performed to treat the adverse event.
Additional Manufacturer Narrative
Additional info: b5, d10, d11, d10, g7, g9, h2, h3, h6, h10.Results of investigation: the devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this is a journey ii bcs-eu study.It was reported that patient presents with left patellofemoral pain.Low patellar tilt and lateralization of patella.It is noted a patellar multi-tracking revision is planned and scheduled for after summer 2020.To date no medical/clinical documentation has been provided.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event of medical/clinical records being received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely device malalignment.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that several patients present patellofemoral pain.Low patellar tilt and lateralization of patella.Patellar maltracking.Revision surgery scheduled after summer 2020.
Event or Problem Description
It was reported that several patients present patellofemoral pain.Low patellar tilt and lateralization of patella.Patellar maltracking.Revision surgery was performed on september 16th.The patella was resurfaced and no component was removed.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 7
• Common Device Name: PROSTHESISKNEPATELOFMOROTIBIALSEMICONSTRAINDCMNTDPOLYMRMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9881291
• Report Number: 1020279-2020-01018
• Device Sequence Number: 16904348
• Product Code: JWH
• UDI-Device Identifier: 00885556170519
• UDI-Public: 00885556170519
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74022127
• Device Catalogue Number: 74022127
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020; 09/22/2020; 11/26/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/13/2020; 10/06/2020; 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022227, JOURNEY TIBIA PLATE, LOT:UNKNOWN.; 74027281, JOURNEY II XLPE INSERT, LOT:UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention