MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 8 {} LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420174
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
Event or Problem Description
It was reported a revision surgery was performed to remove the tibial baseplate due to loosening and to resurface the patella due to knee pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.[(b)(4)].
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.
Additional Manufacturer Narrative
Investigation summary was not attached by error to supplemental report.Report 1020279-2017-00481 with follow up 002 was submitted, since submission from report 1020279-2017-00481 with follow up 001 failed.(b)(4).

• Brand Name: GNS II CMT TIB SIZE 8 {} LT
• 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: 6669950
• Report Number: 1020279-2017-00481
• Device Sequence Number: 13694198
• Product Code: JWH
• UDI-Device Identifier: 03596010206305
• UDI-Public: 03596010206305
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/11/2017

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: 11/01/2023
• Device Model Number: 71420174
• Device Catalogue Number: 71420174
• Device Lot Number: 13KT36250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 06/06/2017; 06/06/2017; 06/06/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 10/10/2017; 10/11/2017; 10/11/2017
• 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: 71421217/13KM18612, LEGION PS OXINIUM; 71421523/13BT28079, GII PS INSERT; V0100022, VISIONAIRE CUTTING BLOCK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR