MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021167
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a left tka surgery performed on (b)(6) 2018, the patient experienced a non-occlusive low echogenicity thrombosis within the popliteal vein on (b)(6) 2018.To treat the condition the patient was administered medication.The condition was reported as resolved with sequelae on (b)(6) 2019.Further details regarding the patient's current health condition and the specific details of the sequelae are currently unknown.
Additional Manufacturer Narrative
Internal complaint number: case (b)(4).
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, the provided adverse event form documents onset (b)(6) 2018 of the moderately (severe) adverse event #1 as unrelated to the device but definitely related to the procedure which was resolved with sequelae (stop date of (b)(6) 2019).Tourniquet time was noted to be 50 minutes.Post-surgical thrombus formation is a known procedural risk factor/potential complication and does not indicate a component mal-performance or failure.Based on the limited information provided, definitive contributing clinical factors cannot be concluded.The patient impact beyond the post-op thrombosis and subsequent medication therapy cannot be determined.The patient current health status is unknown; however, per the documentation, the event resolved with sequelae.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 device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that hematoma, thromboembolic diseases including venous thrombosis, pulmonary embolus, or myocardial infarction, damage to blood vessels have been identified in possible adverse effects section.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 evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.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 LT SZ 7
• 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: 18423034
• Report Number: 1020279-2023-02639
• Device Sequence Number: 20824405
• Product Code: JWH
• UDI-Device Identifier: 00885556422762
• UDI-Public: 00885556422762
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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
• Device Expiration Date: 11/01/2025
• Device Catalogue Number: 74021167
• Device Lot Number: 15LM03006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/31/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male