MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT 9; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023231
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a during a tka procedure, revision surgery was performed and the articular insert post was found to be damaged.No delay reported.Backup device available.No injury or impact to patient reported.
Additional Manufacturer Narrative
Additional information obtained: lot number added.
Additional Manufacturer Narrative
The associated journey bcs articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated that damage and deformation was observed on the articular surface of the insert; these features have been reported as being created by third-body particulate (bone cement, bone, etc.) in the joint space.Cement and bone particulate are known to be produced during a total knee arthroplasty, even under carefully controlled conditions.The locking mechanism is damaged, likely due to removal.The post is deformed.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical analysis noted there was no injury or impact to patient reported.Since no patient injury is being reported, no further medical assessment is warranted.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURN ART INS BCS STD 3-4 RT 9
• 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: 8245644
• Report Number: 1020279-2019-00162
• Device Sequence Number: 2010368
• Product Code: JWH
• UDI-Device Identifier: 03596010554994
• UDI-Public: 03596010554994
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74023231
• Device Lot Number: 10GM12270
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 12/20/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 04/01/2019; 04/07/2019
• 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