MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ5-6 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMENTD,POLYMR/METAL/POLYMER

Catalog Number	71420542
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to a loose poly insert.
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).

• Brand Name: GNS II CON INS SZ5-6 15MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMENTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6927046
• Report Number: 1020279-2017-00838
• Device Sequence Number: 13781048
• Product Code: JWH
• UDI-Device Identifier: 03596010208132
• UDI-Public: 03596010208132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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 Expiration Date: 09/01/2019
• Device Catalogue Number: 71420542
• Device Lot Number: 09JM02564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/07/2017
• Supplement Report FDA Received Date: 01/29/2018
• 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
• Patient Age: 35 YR
• Patient Weight: 150