MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 5; 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	Insufficient Information (4580)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after total left knee arthroplasty was conducted on (b)(6) 2017, an incision drainage was performed on (b)(6) 2017.Patient's symptoms/medical conditions experienced previous to the drainage are unknown.The issue was resolved with this medical intervention.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: JRNY II CR FEM OX NP LT SZ 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12537805
• Report Number: 1020279-2021-07207
• Device Sequence Number: 1414768
• Product Code: JWH
• UDI-Device Identifier: 00885556422786
• UDI-Public: 00885556422786
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 17EM19959
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other