MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74027272
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/14/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following tka patient developed a knee infection which was solved with antibiotic therapy and surgical approach which included exchange of tibial insert.Right knee complication included drainage, swelling and flu-like symptoms.Aspirate of right knee effusion revealed infection - (b)(6).Event is resolved and patient was doing well on follow-up appointment (b)(6) 2012.
Additional Manufacturer Narrative
Correction based on additional information received.
Additional Manufacturer Narrative
Please review attached for the 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.
Additional Manufacturer Narrative
Please take in consideration the file for the previous report submitted.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 RT 10MM
• 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: 6636213
• Report Number: 1020279-2017-00416
• Device Sequence Number: 613974
• Product Code: JWH
• UDI-Device Identifier: 00885556179765
• UDI-Public: 00885556179765
• 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: 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: 74027272
• Device Catalogue Number: 74027272
• Device Lot Number: 11LM09980A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 08/01/2017; 08/01/2017; 08/01/2017; 08/01/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 08/03/2017; 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 7, 74022217 / UNK LOT; JRNY BCS II FEMORAL OXIN RT SZ 7, 74022117/UNK LOT; JRNY BCS PAT RESRF RD 41 MM STD, 74024841/UNK LOT
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 127