MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022225
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/04/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision of total left knee arthroplasty with exchange of tibial baseplate and articular insert due to painful left knee loosening of tibial insert.
Additional Manufacturer Narrative
Please review attached for the investigation results.

• Brand Name: JOURNEY TIBIA BASE NP LT 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: 6957324
• Report Number: 1020279-2017-00880
• Device Sequence Number: 682655
• Product Code: JWH
• UDI-Device Identifier: 03596010554338
• UDI-Public: 03596010554338
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 12/16/2022
• Device Catalogue Number: 74022225
• Device Lot Number: 12MM10437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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: JRNYIIBCS XLPE ISRT SZ5-6LT9MM,74027261/13BM07555
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 195