MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420168
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.(b)(4).

• Brand Name: GNS II CMT TIB SIZE 5 {} LEFT
• 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: 6881283
• Report Number: 1020279-2017-00771
• Device Sequence Number: 566761
• Product Code: JWH
• UDI-Device Identifier: 03596010206275
• UDI-Public: 03596010206275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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 Catalogue Number: 71420168
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention