MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number 74027262

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Injury (2348)

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.We consider this investigation closed.

Event Description

It was reported that patient had knee effusion and required an aspiration.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM
• Type of Device: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 8518973
• MDR Text Key: 142092376
• Report Number: 1020279-2019-01579
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556178010
• UDI-Public: 00885556178010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Catalogue Number: 74027262
• Device Lot Number: 13MM08411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• Date Device Manufactured: 12/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention