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

Catalog Number	71420191
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	04/07/2017
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
Revision for a genesis ii tibial baseplate was performed for suspected peri-prosthetic fracture 4 weeks post op.
Additional Manufacturer Narrative
Please see attached for the investigation results.(b)(4).

• Brand Name: GNS II CEM TIB SIZE 8 RIGHT
• 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: 6533700
• Report Number: 1020279-2017-00302
• Device Sequence Number: 719406
• Product Code: JWH
• UDI-Device Identifier: 03596010206381
• UDI-Public: 03596010206381
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 08/10/2025
• Device Catalogue Number: 71420191
• Device Lot Number: 15HM09162
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention