MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6RM/LL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422266

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/20/2018

Event Type  Injury  

Event Description

It was reported that the uni implants failed as per surgeon dr.(b)(6).Revision surgery performed to explant devices.Unable to see lots due to bone ingrowth.

Manufacturer Narrative

The affected juni oxinium femoral component, journey uni tibial baseplate and journey uni tibial insert were returned and evaluated.From the analysis conducted during this investigation, the lab noted that the femoral implant showed bone and/or bone cement was observed on the bone contacting surfaces and appeared well-attached.Damage was observed along the rail of the cement pocket.Both sides of the articular surface also showed damage and gouged material on the articular surface.The insert had damage on the distal surface of the insert starting along the medial edge and moving anteriorly.It also showed wear along the articular surface with more damage near the anterior edge.The baseplate showed surface scratches along the proximal surface and edge of the baseplate.Burnishing was observed near the anterior side of the bone-contacting surface.No bone cement was visible on the bone-contacting surface.No material or manufacturing defects were observed in any of the components in the course of this investigation.A clinical evaluation noted that although the lab analysis reported poor bone attachment may have contributed to the loosening and subsequent failure of the device; there were no clinical supporting documents nor operative findings provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered due to the lack of relevant clinical documents.Only a review of the manufacturing records for the baseplate is possible as batch number for femoral component and insert is not legible.This review did not reveal any deviation from the standard manufacturing processes.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY UNI TIBINRT S5-6RM/LL9MM
• 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: 7970321
• MDR Text Key: 123863156
• Report Number: 1020279-2018-02173
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582256
• UDI-Public: 03596010582256
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• 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: 01/18/2019

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: 71422266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR