MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT10; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74023232
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was done on the patient.Reason for revision - pt slipped at work resulting in instability.At revision, insert exchanged for a journey bcs revision insert.At time of removal, unusual wear patten noticed and commented on by surgeon.Patient fit and healthy.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis of the journ art ins bcs std 3-4 rt10 revealed the wear on the articular surface was likely due to normal articulation between the insert and femoral component.Burnishing was observed on the inferior surface of the insert.No discernible damage or material deformation was present on the insert post.No material or manufacturing deviations were observed during this investigation.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 3-4 RT10
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7814914
• Report Number: 1020279-2018-01625
• Device Sequence Number: 1952716
• Product Code: JWH
• UDI-Device Identifier: 03596010555007
• UDI-Public: 03596010555007
• 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): 11/22/2018

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 Expiration Date: 06/24/2022
• Device Catalogue Number: 74023232
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 01/23/2019
• 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