MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3; FEMORAL COMPONENT

Catalog Number 71335552

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 09/13/2011

Event Type  Injury  

Event Description

It was reported that the patient was re-admitted for 2cm mass aspiration and incision and drainage.

• Brand Name: R3
• Type of Device: FEMORAL COMPONENT
• 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: melanie travis ; 1450 brooks road; memphis, TN 38116 ; 9013996233
• MDR Report Key: 4553817
• MDR Text Key: 5520964
• Report Number: 1020279-2015-00101
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 71335552
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1