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
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to unexplained pain.No more information provided yet.
Additional 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
• 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: 8582460
• Report Number: 1020279-2019-01757
• Device Sequence Number: 3236711
• Product Code: HSX
• UDI-Device Identifier: 00885556088296
• UDI-Public: 00885556088296
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K102069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71422434
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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