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

Catalog Number 71422235

Device Problem Fracture (1260)

Patient Problem Toxicity (2333)

Event Date 06/01/2014

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that a revision right knee surgery was performed due to implant fracture.During the procedure it was discovered the baseplate fractured in seven or eight places with moderate sized-effusion and metallosis throughout.Extensive synovectomy was performed during the revision.

Manufacturer Narrative

The associated device was not returned for evaluation.This device is included in the scope of a previous field action launched in 2009.No further investigation warranted at this time.

Manufacturer Narrative

Correction.

• Brand Name: JOURNEY UNI TIB BASE RM/LL SZ 5
• Type of Device: TIBIAL BASEPLATE
• 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: 5117974
• MDR Text Key: 27273066
• Report Number: 1020279-2015-00700
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Catalogue Number: 71422235
• Device Lot Number: 08MM13038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2008
• 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-0924-2010/ Z-0967-2010
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention