MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK DIS FEM WDG SZ5 5MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422159

Device Problem Insufficient Information (3190)

Patient Problem Cellulitis (1768)

Event Date 07/07/2017

Event Type  Injury  

Event Description

It was reported that patient presented with an infection a week after he underwent unknown procedure, weeks later on (b)(6), he was hospitalized due to cellulitis on left anterior leg.

Manufacturer Narrative

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

• Brand Name: LGN HK DIS FEM WDG SZ5 5MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7054724
• MDR Text Key: 92831724
• Report Number: 1020279-2017-01095
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556029848
• UDI-Public: 00885556029848
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081111
• 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: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71422159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: No
• 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; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 114