MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 15MM BOLT - SLEEVE; PROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAIND,CMNTD,METAL/POLYMR

Catalog Number 71421387

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

• Brand Name: LEGION HK 15MM BOLT - SLEEVE
• Type of Device: PROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAIND,CMNTD,METAL/POLYMR
• 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: 7054729
• MDR Text Key: 92831567
• Report Number: 1020279-2017-01096
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556030004
• UDI-Public: 00885556030004
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

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 Catalogue Number: 71421387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: No
• 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