MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 3-4 RT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023830
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient required a revision surgery because of pain and discomfort.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, (b)(6) based on the information provided, the ¿stiffness and pain¿ experienced by the patient was likely a normal progression of the post-operative healing phase and not a failure of the s&n device.Information around the patient¿s post-operative rehabilitation prior to this mua is not available.Pre mua range was 10-35 degrees; post mua rom was reported as 0-140 degrees.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported pain and discomfort and cannot be determined.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.
Additional Manufacturer Narrative
Correct explant date added.

• Brand Name: JRNY II XR INS XLPE LAT 3-4 RT 8MM
• 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: 8269169
• Report Number: 1020279-2019-00250
• Device Sequence Number: 11164302
• Product Code: JWH
• UDI-Device Identifier: 00885556615607
• UDI-Public: 00885556615607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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: 11/27/2025
• Device Catalogue Number: 74023830
• Device Lot Number: 15LM19474
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 12/31/2018; 12/31/2018
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 05/20/2019; 06/20/2019
• 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