MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 10MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74025632
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized and treated with eliquis due to lower extremity deep vein thrombosis.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 3-4 10MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8886070
• Report Number: 1020279-2019-03030
• Device Sequence Number: 14065318
• Product Code: JWH
• UDI-Device Identifier: 00885556422595
• UDI-Public: 00885556422595
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2019

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: 74025632
• Device Lot Number: 17GM13593
• Initial Date Received by Manufacturer: 07/13/2019
• Supplement Date Received by Manufacturer: 07/13/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/09/2019
• 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