MAUDE Adverse Event Report: BROOKS MANUFACTURING SITE R3; FEMORAL COMPONENT

Catalog Number OR71335752

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/20/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.

Manufacturer Narrative

• Brand Name: R3
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): BROOKS MANUFACTURING SITE; 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 38116 ; 9013996233
• MDR Report Key: 3689126
• MDR Text Key: 4242185
• Report Number: 1020279-2014-00180
• 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: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OR71335752
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization