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

Model Number	74022115
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/01/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was treated with weekly antibiotic therapy (bactrim ds 800/160 2x1) due to post-operative drainage of the right knee.Event was described as non-serious, of mild severity, not related to study device and possibly related to study procedure and was deemed solved.
Additional Manufacturer Narrative
Corrections based on new information received.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).
Additional Manufacturer Narrative
Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• 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: 6639438
• Report Number: 1020279-2017-00421
• Device Sequence Number: 16414526
• Product Code: JWH
• UDI-Device Identifier: 00885556169919
• UDI-Public: 00885556169919
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/29/2018

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: 74022115
• Device Catalogue Number: 74022115
• Device Lot Number: 12BM01683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 07/31/2017; 07/31/2017; 07/31/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 08/08/2017; 10/05/2017; 05/23/2018; 05/29/2018
• 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 RT SZ 3, 74022213/UNK LOT; JRNY BCS PAT RESRF RD 35 MM STD, 74024835/UNK LOT; JRNYIIBCS XLPE ARTISRT SZ3-4RT10MM, 74027232/UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 69