MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	74022116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	12/22/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery due to painful right knee, recurrent effusion (no infection) and chronic instability.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see 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 6
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6829613
• Report Number: 1020279-2017-00675
• Device Sequence Number: 19190199
• Product Code: JWH
• UDI-Device Identifier: 00885556169964
• UDI-Public: 00885556169964
• 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
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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 Expiration Date: 12/28/2021
• Device Catalogue Number: 74022116
• Device Lot Number: 11MM00665
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 08/30/2017; 08/30/2017; 08/30/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 09/01/2017; 11/08/2017; 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 5,(B)(4); JRNY BCS PAT RESRF RD 38 MM STD,(B)(4); JRNY II BCS XLPE ART ISRT SZ 5-6 RT 11MM,(B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 86