MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT15; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74023235

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 09/18/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed.The poly was explanted due to wear.

Manufacturer Narrative

The associated device was returned and evaluated.The insert was examined macroscopically.No destructive testing was conducted during this analysis.Deformation and burnishing of the articular surface of the insert is visible.The post and the anterior lock of the insert showed signs of damage and deformation.The damage to the anterior lock was likely caused by an instrument during removal of the implant.The damage to the posterior surface of the insert post was likely caused due to contact with the femoral cam during expected use in vivo.Additionally the edge of the anterior locking mechanism appeared slightly deformed.This indicates that the insert was likely fully seated when implanted.No material or mechanical deviations were noted during this investigation.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 3-4 RT15
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7962895
• MDR Text Key: 123665633
• Report Number: 1020279-2018-02122
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010555038
• UDI-Public: 03596010555038
• Combination Product (y/n): N
• PMA/PMN Number: K042515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Catalogue Number: 74023235
• Device Lot Number: 06HM15094
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention