MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 41 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74024841
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/13/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Later on patient had a patellar fracture on contralateral anatomy due to trauma, which has been reported via 1020279-2017-00692.
Event or Problem Description
It was reported that patient had fractured left knee patella as a result of trauma.It was reported that action taken to solve this problem was a surgical procedure, but also that this patient has not had revision surgery of the left knee.
Event or Problem Description
Patient was advised to use crutches as well as knee immobiliser and to report to orthopedics as per pre-scheduled appointment.
Additional Manufacturer Narrative
Corrected data received from the study site indicated that no remedial therapy was done to solve this problem.

• Brand Name: JRNY BCS PAT RESRF RD 41 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6840868
• Report Number: 1020279-2017-00694
• Device Sequence Number: 117145
• Product Code: JWH
• UDI-Device Identifier: 03596010554567
• UDI-Public: 03596010554567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: 74024841
• Device Lot Number: 13CM05013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 09/05/2017; 10/13/2017; 10/13/2017
• Initial Report FDA Received Date: 09/04/2017
• Supplement Report FDA Received Date: 09/26/2017; 10/25/2017; 11/07/2017
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 108