MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 1; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422421

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 08/06/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening of the device.Pain was also reported due to this issue.

Manufacturer Narrative

The affected journey uni tibial baseplate and journey uni tibial insert were returned and evaluated.A lab analysis conducted during this investigation indicated that wear and deformation are present on the articulating surface of the insert.The non-articulating surface and the side of the insert have scratches and deformation.The locking mechanism on the insert and on the baseplate are damaged, likely due to detachment of the insert from the baseplate.The cement contacting surface of the baseplate shows signs of burnishing.The roughness value of the cement contacting surface of the baseplate was measured in a region with no apparent burnishing found to be within the roughness specification range.There were no observations of material or manufacturing deviations in the course of this investigation.Our clinical analysis noted that no clinically relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.The patient impact beyond the expected post-op convalescence cannot be determined.No further medical assessment is warranted at this time.Our investigation including a review of the manufacturing records of the baseplate for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the baseplate revealed no prior complaints for the listed failure mode with the same batch number.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JRNY UNI TIBIAL BASE LM/RL SZ 1
• 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: 7807004
• MDR Text Key: 117924163
• Report Number: 1020279-2018-01599
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556087848
• UDI-Public: 00885556087848
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422421
• Device Lot Number: 16EM12823
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention