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
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening of the device.Pain was also reported due to this issue.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7807004
• Report Number: 1020279-2018-01599
• Device Sequence Number: 1637682
• Product Code: HSX
• UDI-Device Identifier: 00885556087848
• UDI-Public: 00885556087848
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: 01/12/2026
• Device Catalogue Number: 71422421
• Device Lot Number: 16EM12823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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