MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. REV JOURNEY ART INS BCS STD 7-8 LT 15; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71934546
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complained of pain and swelling.Surgery scheduled to identify issue and it was noticed the insert was not completely locked into tibia base.Removed insert and replaced with jii constrained insert.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Our assessment revealed the rev journey art ins bcs std 7-8 lt 15 show scratches and damaged at the locking site.The engineering evaluation concluded, the device shows significant wear and damage at the locking detail.A dhr review shows no manufacturing issues or device nonconformances that could have caused or contributed to the reported incident.A dimensional inspection was attempted but the deformation of the device would not allow for accurate measurement.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.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: REV JOURNEY ART INS BCS STD 7-8 LT 15
• 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: 7805309
• Report Number: 1020279-2018-01572
• Device Sequence Number: 11100514
• Product Code: JWH
• UDI-Device Identifier: 00885556183168
• UDI-Public: 00885556183168
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110837
• 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
• Report Date (Section B): 05/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2021
• Device Catalogue Number: 71934546
• Device Lot Number: 11CM05394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 05/06/2019
• 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: Congenital Anomaly; Hospitalization