MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 6 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED

Model Number 71422356

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 08/15/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to a loose tibial insert.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).

• Brand Name: JUNI OX FB FEM SZ 6 RM LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED
• 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: kenney mccaster ; 1450 e. brooks rd.; memphis, TN 38116
• MDR Report Key: 6844519
• MDR Text Key: 84959303
• Report Number: 1020279-2017-00707
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627421
• UDI-Public: (01)03596010627421(17)260704(10)16GM03577
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 71422356
• Device Catalogue Number: 71422356
• Device Lot Number: 16GM03577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 96