MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2019, the patient experienced vein thrombosis on the left lower extremity.This adverse event was treated with medication & physical therapy.Patient's current health status is recovered.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the study patient experienced adverse event vein thrombosis on the left lower extremity post left jii xr total knee arthroplasty which was resolved with medication and physical therapy.The jii xr pmcf operative data for (b)(6) 2019 surgery date documents 94 minutes total tourniquet time.As of the date of this medical investigation, further details such as symptom onset remain unknown; however, the concomitant medication documentation shows heparin was started approximately two weeks post total knee arthroplasty on (b)(6) 2019 and ended (b)(6) 2019 for the associated.The occurrence of post-operative deep vein thrombosis is a known potential risk/adverse hematological event and is not indicative of any component malperformance.Based on the information provided, no further clinical factors could be definitively concluded to have contributed to the reported event.Patient impact beyond the reported post-primary total knee arthroplasty lower leg thrombosis and subsequent medication along with physical therapy would not be anticipated as the event was reportedly resolved.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that thromboembolic diseases including venous thrombosis has been identified in possible adverse effects.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 post-operative healing issue and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 CR FEM OX NP LT SZ 4
• 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: 16569273
• Report Number: 1020279-2023-00577
• Device Sequence Number: 12132701
• Product Code: JWH
• UDI-Device Identifier: 00885556422793
• UDI-Public: 00885556422793
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 74021164
• Device Catalogue Number: 74021164
• Device Lot Number: 18EM00183
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420566 / 19BM18168.; 74022203 / 18ESL0008.; 74023740 / 17LM18849.; 74023840 / 18AM00951.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female