MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 5; PROST, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	74021155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject presented postoperative right knee stiffness.The event was treated via manipulation under anesthesia.

• Brand Name: JRNY II CR FEM OX NP RT SZ 5
• Common Device Name: PROST, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10015770
• Report Number: 1020279-2020-01431
• Device Sequence Number: 2436915
• Product Code: JWH
• UDI-Device Identifier: 00885556422847
• UDI-Public: 00885556422847
• 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,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2020

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 Expiration Date: 03/08/2025
• Device Model Number: 74021155
• Device Catalogue Number: 74021155
• Device Lot Number: 15HM03842
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 12/09/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 12/10/2020; 12/10/2020
• 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