MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT BICONVEX 26 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	74024626
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Swelling (2356); Joint Dislocation (2374)
Date of Event	10/10/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had an injury playing golf in which he felt a pop and pain/swelling in the knee.X-ray showed patellar component dislodged and removal of patella was done arthroscopically.After removal of patellar component, patient failed to improve and on (b)(6) 2015 knee revision of the patellar component with a possible lateral release was done.
Additional Manufacturer Narrative
A correction based on new information received.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: JRNY BCS PAT BICONVEX 26 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6844520
• Report Number: 1020279-2017-00706
• Device Sequence Number: 60114
• Product Code: JWH
• UDI-Device Identifier: 03596010554475
• UDI-Public: 03596010554475
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: 74024626
• Device Lot Number: 13AM15088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 09/07/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 09/19/2017; 10/31/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 105