MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBIAL BASE LM/RL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422423

Device Problem Collapse (1099)

Patient Problem Injury (2348)

Event Date 02/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a revision surgery was performed on the left knee due to collapse of the tibial plate and degenerative changes.

• Brand Name: JOURNEY UNI TIBIAL BASE LM/RL SZ 3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: claudia odoy ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6106392
• MDR Text Key: 60021729
• Report Number: 1020279-2016-00882
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2022
• Device Catalogue Number: 71422423
• Device Lot Number: 12GM04722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2012
• 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
• Treatment: JOURNEY FEMORAL HEAD PART#71422344 LOT#13DM18720; JOURNEY TIBIAL INSERT PART#71422251 LOT#13AM1095J
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR