MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422434

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 04/09/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to unexplained pain.No more information provided yet.

Manufacturer Narrative

It was reported that a revision surgery was performed due to unexplained pain.The associated journey uni tibial baseplate and other devices were not returned for analysis.Therefore a product evaluation could not be performed.Only the baseplate was provided with the product information.No part/batch was available for other devices.However, our investigation including a review of the manufacturing records for the listed baseplate 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.A clinical evaluation noted that based on both images provided, it shows radiolucency under the tibial base plate which could indicate loosening but the revision report wasn¿t available to confirm.It has been communicated that no additional relevant supporting clinical information is available.Based on the limited clinical information the root cause of the persistent knee pain cannot be confirmed but tibial loosening cannot be ruled out.The patient impact beyond the reported pain is undetermined.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY UNI TIBIAL BASE RM/LL SZ 4
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8582460
• MDR Text Key: 144142779
• Report Number: 1020279-2019-01757
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556088296
• UDI-Public: 00885556088296
• Combination Product (y/n): N
• PMA/PMN Number: K102069
• 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: 10/21/2019

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 Catalogue Number: 71422434
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention