MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 35 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74024835
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject was hospitalized due to a fall.The patient suffered from wound dehiscence due to the fall and spent 10 days in the hospital.

• Brand Name: JRNY BCS PAT RESRF RD 35 MM STD
• 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: 9832151
• Report Number: 1020279-2020-00887
• Device Sequence Number: 740839
• Product Code: JWH
• UDI-Device Identifier: 03596010554543
• UDI-Public: 03596010554543
• Combination Product (Y/N): N
• PMA/510(K) Number: K042515
• 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): 12/15/2020

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: 74024835
• Device Catalogue Number: 74024835
• Device Lot Number: 18DM16835
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 12/12/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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