MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 5; PROSTHESISKNEPATELOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMRMETALPOLYMER

Model Number	74021165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented stiffness of left knee.Event was treated with manipulation under anesthesia.

• Brand Name: JRNY II CR FEM OX NP LT SZ 5
• Common Device Name: PROSTHESISKNEPATELOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMRMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9951763
• Report Number: 1020279-2020-01270
• Device Sequence Number: 3272599
• Product Code: JWH
• UDI-Device Identifier: 00885556422786
• UDI-Public: 00885556422786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 17FM03777G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 04/11/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention