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

Catalog Number 71422251

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a revision surgery was performed to replace the poly insert due to disassociation.During the surgery, it was determined to revise the tibia as well since the new poly would not lock onto it.

• Brand Name: JOURNEY UNI TIBINRT S3-4LM/RL8MM
• Type of Device: UNICONDYLAR KNEE 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5894910
• MDR Text Key: 52721125
• Report Number: 1020279-2016-00656
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422251
• Device Lot Number: 15MM03528
• 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: 08/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• 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