MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT 9; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	OR74023261
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a case was booked as a left journey insert exchange.On discussion with the surgeon prior to the start of the surgery, he indicated that the patient had previously had a knee arthroscopy of the same knee and the post of the polyethylene had broken off and been removed.During the insert exchange surgery the surgeon removed the polyethylene (sz 5-6 9mm) using a bristow and mallet.He proceeded to removed any tissue that may inhibit the insertion of the new polyethylene and trialled with an insert 2mm thicker than the original size.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A lab analysis indicated that some burnishing was visible on the articulating surface of the insert.This was likely caused by femoral component articulation.The inferior surface show signs of deformation on the locking mechanism.Discoloration of the insert is likely attributed to absorbed biological fluid.The post is fractured as reported.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical analysis indicated that there have been multiple unsuccessful attempts to obtain supporting clinical/medical documentation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 5-6 LT 9
• 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: 7509699
• Report Number: 1020279-2018-00916
• Device Sequence Number: 1333735
• Product Code: JWH
• UDI-Device Identifier: 03596010555205
• UDI-Public: 03596010555205
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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 Catalogue Number: OR74023261
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/13/2018
• Supplement Report FDA Received Date: 12/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention