MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420188
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	04/28/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that years after tka the patient experienced a pulmonary embolism.Adverse event is considered to be definitely related to the right knee procedure.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient¿s current medical status has been reported as resolved.Based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: GNS II CMT TIB SIZE 6 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8624325
• Report Number: 1020279-2019-01970
• Device Sequence Number: 11254774
• Product Code: JWH
• UDI-Device Identifier: 03596010206367
• UDI-Public: 03596010206367
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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: 71420188
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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