MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
Event or Problem Description
It was reported a revision surgery was performed for a patella resurfacing as the patient complained of persistent anterior knee pain.None of the original components needed revising at this time.
Additional Manufacturer Narrative
Please see attached for the investigation results.(b)(4).

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 5
• 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: 6453650
• Report Number: 1020279-2017-00235
• Device Sequence Number: 874234
• Product Code: JWH
• UDI-Device Identifier: 00885556169919
• UDI-Public: 00885556169919
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 12/01/2025
• Device Catalogue Number: 74022115
• Device Lot Number: 15MM03314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: PART#74022214 LOT#15KM15203; PART#74027231 LOT#15LM18542
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR