MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	74022217
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	02/13/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a knee revision was performed.There is no information given why revision was done.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 7
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6791447
• Report Number: 1020279-2017-00625
• Device Sequence Number: 1116567
• Product Code: JWH
• UDI-Device Identifier: 03596010554390
• UDI-Public: 03596010554390
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: 02/08/2021
• Device Catalogue Number: 74022217
• Device Lot Number: 11BM07107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 74022118/12CM12255; 74024626/08KM09277; 74027271/12BM00586
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR