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

Catalog Number 71422235

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 10/29/2015

Event Type  Injury  

Event Description

It was reported that a revision knee surgery was performed due to a tibial baseplate fracture and a loose patella.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned device revealed the uni tibial baseplate has fractured in half.All devices resemble typical explanted devices.The part and lot are unknown for the patellar and femoral components.A review of the device information provided indicates that the reported device was part of field action initiated in 2009.No further investigation warranted at this time.

• 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: 5246608
• MDR Text Key: 32031718
• Report Number: 1020279-2015-00808
• 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: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2019
• Device Catalogue Number: 71422235
• Device Lot Number: 09DM07604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2009
• 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-0933-2010
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 97