MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a right tka had been performed on (b)(6) -2018, the patient experienced a contracture on (b)(6) 2019, approximately one year after surgery.A non-invasive joint mobilization procedure was performed on (b)(6) 2019, and the patient was discharged from the hospital on (b)(6) 2020.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the study patient underwent a right knee non-invasive joint mobilization approximately 13 months post-tka due to range of motion failure/contracture (ae#1).The post-market clinical follow-up adverse event and serious adverse event forms show start date of the anticipated, moderate severity serious adverse event as (b)(6) 2019 and document the (ae#1) unrelated to the study device but possibly related to the study procedure.Hospitalization/admit date noted as (b)(6) 2019, right knee joint mobilization on (b)(6) 2019 with hospital discharge/stop date on (b)(6) 2020 with a recovering/resolving outcome.Based on the information provided in the post-market clinical follow-up adverse event and serious adverse event forms, no further clinical factors could be definitively concluded to have contributed to the reported event; however, a reduction in post-operative range of motion is a known possible risk following surgical joint procedures and may result from many contributing factors not indicative of a malperformance of the component(s).The patient impact was the reported post-op range of motion failure/contracture, subsequent non-invasive manipulation, and hospitalization.The outcome was reported as recovering/resolving.No further medical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in possible adverse effects that flexion contracture can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should 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 CR FEM OX NP RT SZ 6
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16570456
• Report Number: 1020279-2023-00583
• Device Sequence Number: 17330522
• Product Code: JWH
• UDI-Device Identifier: 00885556422830
• UDI-Public: 00885556422830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 74021156
• Device Catalogue Number: 74021156
• Device Lot Number: 17DM08495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/19/2023
• Supplement Report FDA Received Date: 04/18/2023
• Date Device Manufactured: 04/12/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male