MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 3-4 RT 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Model Number	74023830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a primary journey xr knee replacement was done by another surgeon in (b)(6) 2020.Then, the patient was revised on (b)(6) because the patient complained of knee pain and could not flex the knee past 95 degrees after the initial operation.The surgeons identified that the problem was because the joint line was raised by about 10 mm and the tibial slope was decreased from about 10 degrees to zero.
Additional Manufacturer Narrative
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, this case reports a journey ii revision was performed due to pain and decreased flexion.Per email communication, there is no additional information available to fully evaluate the root cause of the reported event.Without clinically relevant patient-specific supporting documentation a thorough medical investigation cannot be performed.No further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed device.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.Some potential probable causes could be alignment, fit/size of device used or wear.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 XR INS XLPE LAT 3-4 RT 8MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11069704
• Report Number: 1020279-2020-07754
• Device Sequence Number: 14254830
• Product Code: JWH
• UDI-Device Identifier: 00885556615607
• UDI-Public: 00885556615607
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74023830
• Device Catalogue Number: 74023830
• Device Lot Number: 18ESL0015
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 07/20/2021
• 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