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

Catalog Number 71422235

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 09/18/2012

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed.

Manufacturer Narrative

Manufacturer Narrative

Devices were returned and evaluated.The journey uni femoral and tibial baseplate components had bone cement and bone on growth on the grit-blasted surface.The bone cement and bone on growth appeared well adhered to the component as it did not become dislodged with the manual application of force by hand.The articulating surface appeared intact.The baseplate showed signs of burnishing on the superior surface.The journey uni tibial baseplate was also fractured.Examination of the fracture surfaces via scanning electron microscopy indicated that burnishing marks were present on the fracture surfaces.Burnishing marks can be indicative of a component failing due to metal fatigue cracking.The baseplate potentially fractured by the initiation and subsequent propagation of metal fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the baseplate could not bear the imposed patient loading, which led to an overload fracture.The journey uni tibial insert showed signs of wear marks and deformation on the superior articulating surface.The insert inferior surface showed signs of deformation consistent with dissociation from the baseplate, indicating the insert was likely positioned on top of the baseplate locking mechanism.It is unknown if this damage occurred prior to or after the fracture of the baseplate.The insert also showed signs of metal particulate embedment on the inferior surface.This particulate embedment was likely caused due to the aforementioned micro-motion between the baseplate and the insert.The posterior lock of the insert showed signs of deformation that are consistent with the insert not being properly locked within the baseplate.On december 23, 2009, smith & nephew initiated a voluntary recall of all lots of journey uni tibial baseplates.Corrective actions were implemented to prevent recurrence of this failure mode.Credit cannot be issued for the devices.

• 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4338511
• MDR Text Key: 5203352
• Report Number: 1020279-2014-00756
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2017
• Device Catalogue Number: 71422235
• Device Lot Number: 07DM16210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0924-0967-2010
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention