MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB BASE LM/RL SZ 6; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422226

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/27/2017

Event Type  Injury  

Event Description

It was reported a revision surgery was performed for unspecified reasons.

Event Description

It was reported a revision surgery was performed due to pain associated with a left broken baseplate.

Manufacturer Narrative

Please see attached file for the results of our investigation.(b)(4).

• Brand Name: JOURNEY UNI TIB BASE LM/RL SZ 6
• 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 de santis ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6388275
• MDR Text Key: 69394213
• Report Number: 1020279-2017-00160
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2018
• Device Catalogue Number: 71422226
• Device Lot Number: 08AM09895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/27/2017
• Supplement Dates FDA Received: 03/14/2017; 05/04/2017; 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2008
• 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-0929-2010
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR