MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB BASE RM/LL SZ 5; KNEE PROSTHESIS

Catalog Number 71422235

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 12/18/2013

Event Type  Injury  

Event Description

It was reported that a revision knee surgery was performed due to pain, swelling, and a possible loose tibial component.The patient underwent conversion of the right unicondylar replacement.

Manufacturer Narrative

The affected devices were returned and evaluated.An analysis by our research department concluded the following: bone cement appeared well-adhered to the majority of the bone-interfacing surfaces of the components.A small area of bone cement became dislodged from the femoral component after the application of manual force.This was most likely due to the cement overhanging the component at this location.A fracture, abrasive wear of the articulating surface, and fracture of two posts were observed on the patellar component.Fracture of the component can occur when the forces applied exceed the yield strength of the material.The observed wear of the patellar component could be caused by repeated contact with the edge of the distal trochlear groove during flexion in vivo.The observed overhanging bone cement appears to correspond to the contact location.Deformation was observed on the articulating surface of the tibial insert in the form of a wear track.It was noted the direction of the wear track was not aligned with the anterior/posterior direction of the insert.This could be caused by misalignment of the femoral or tibial component.This can occur during implantation or due to loosening or subsidence after implantation.No manufacturing deviations were noted during visual inspection of the components, and all surfaces showed evidence of fixation in vivo.Based on the analysis conducted, the exact cause of the reported revision was not able to be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY UNI TIB BASE RM/LL SZ 5
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5262076
• MDR Text Key: 32567154
• Report Number: 1020279-2015-00821
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Catalogue Number: 71422235
• Device Lot Number: 07JM10059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 79