MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY II CR KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Contracture (4528)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, 6 weeks after a tka with a journey ii cr knee system, on (b)(6) 2022, patient experienced a flexion contracture, rom 95/5/0.This was address with a manipulation under anesthesia on (b)(6) 2022, a rom of 130/0/0 was achieved.Patient is still recovering.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, the root cause of the reported flexion contracture cannot be definitively concluded.However, we cannot rule out non-compliance with the rehabilitation plan or a possible trauma as likely contributory factors.Therefore, the causal relationship between the s&n device and the reported alleged event cannot be confirmed.Although it was reported the patient started with range of motion (rom) 95/5/0 and the post manipulation under anesthesia (mua) was a rom of 130/0/0, the patient impact beyond the limited range of motion, and subsequent mua cannot be confirmed nor concluded since it was reported the patient is still recovering.Should any additional relevant medical information be provided, this case would be re-assessed.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 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 as a possible adverse effect 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 file 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 this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, rehabilitation plan non-compliance or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.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.Internal complaint reference number: case-2022-00121122-1.

• Brand Name: UNKN JOURNEY II CR KNEE
• 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: 15519463
• Report Number: 1020279-2022-04239
• Device Sequence Number: 6078623
• Product Code: JWH
• UDI-Device Identifier: 00885556422786
• UDI-Public: 00885556422786
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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: 74021165
• Device Catalogue Number: 74021165
• Device Lot Number: 21MM14260
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/05/2022; 11/25/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/06/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71420566; 74022224; 74025641
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown