MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL8MM; KNEE PROSTHESIS

Catalog Number 71422251

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 02/12/2015

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to wear.

Manufacturer Narrative

(b)(4).The associated device was returned and evaluated.The visual inspection of the returned device noted signs of wear/use.The laser etching of the device is not readable.This indicates the insert may have been autoclaved.It should be noted that autoclaving of the insert will cause geometric changes in the device.The device was manufactured in 2008.A dimensional inspection was attempted; however damage/deformation at several features of the device would not allow for accurate measurement.A lab analysis was completed with the following results: damage/deformation and burnishing, could have been created by articulation with the femoral component, this was observed on the superior surface of the liner; some deformation may have been cause by third-body particulate (bone cement, bone, etc.).Damage/deformation was also observed near the periphery of the insert; these features may have been created by instrument contact during revision surgery.The insert may have been sterilized using an autoclave after explantation as no laser markings were visible; such autoclaving limits examination of uhmwpe devices.Features observed on the articular surface of the instrument were consistent with adhesive/abrasive wear and instrument damage.A definitive root cause cannot be determined with the information provided.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.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 TIBINRT S3-4LM/RL8MM
• 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: 4621056
• MDR Text Key: 5574662
• Report Number: 1020279-2015-00130
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2018
• Device Catalogue Number: 71422251
• Device Lot Number: 08AM16263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention