MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT BICONVEX 23 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	74024623
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/26/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent left knee arthroscopy due to lateral patellar facet pain and patellar clunk.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.(b)(4).

• Brand Name: JRNY BCS PAT BICONVEX 23 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6826500
• Report Number: 1020279-2017-00668
• Device Sequence Number: 1521989
• Product Code: JWH
• UDI-Device Identifier: 03596010554468
• UDI-Public: 03596010554468
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/20/2017

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: 10/08/2022
• Device Catalogue Number: 74024623
• Device Lot Number: 12KM06833
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/01/2017; 08/29/2017; 08/01/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 08/31/2017; 09/01/2017; 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP LT SZ 5, 74022225; JRNY BCS II FEMORAL OXIN LT SZ 6, 74022126; JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM, 74027261
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 118