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

Catalog Number	74021254
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after primary cori assisted tka surgery on (b)(6) 2024 where a jrny ii cr system was implanted.Six weeks post-op on 10-abr-2024 the patient presented arthrofibrosis on the right knee, which also caused loss of range of motion.The patient is scheduled for an manipulation under anesthesia on (b)(6) 2024 and their outcome is recovering.Further complications have not been reported.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
B2: outcomes attributed to adverse event.Section h3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the femoral component, the tibial baseplate, the insert and the patella.Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided electronic clinical report forms show the onset date as (b)(6) 2024 for the severe arthrofibrosis, noting the serious event as anticipated, unrelated to the cori tensioner, possibly related to the procedure.A manipulation under anesthesia was performed (b)(6) 2024 and the patient is recovering/resolving.Arthrofibrosis is a known potential post-total knee arthroplasty occurrence and is not indicative of a component malperformance.No contributing clinical factors were identified from the provided electronic clinical report forms.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral component, the insert and the patella, 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 device did not reveal similar events for the listed device.For the tibial baseplate, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in possible adverse effects that decreased range of motion and unusual stress concentrations can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include but not limited to trauma, post operative care, patient medical history 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.H6: health effect - impact code f2308 medical treatment under anaesthesia.

• Brand Name: JRNY II CR FEM COCR NP RT 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: 19259336
• Report Number: 1020279-2024-00886
• Device Sequence Number: 17772024
• Product Code: JWH
• UDI-Device Identifier: 00885556615164
• UDI-Public: 00885556615164
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74021254
• Device Lot Number: B2017863
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022213/23KM00985/JOURNEY TIBIA BASE NP RT SZ 3.; 74024829/15CM18940/JRNY BCS PAT RESRF RD 29 MM STD.; 74025632/20LM03028/JRNY II CR ISRT XLPE RT SZ 3-4.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG