MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT STEM; BASED ON INFORMATION PROVIDED INVOLVING A SMITH AND NEPHEW DEVICE AND AS OUTLINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/22/2017

Event Type  Injury  

Event Description

It was reported a revision surgery was performed to remove a redapt stem for unspecified reasons.

Manufacturer Narrative

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

• Brand Name: REDAPT STEM
• Type of Device: BASED ON INFORMATION PROVIDED INVOLVING A SMITH AND NEPHEW DEVICE AND AS OUTLINE
• 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: claudia de santis ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6419530
• MDR Text Key: 70408909
• Report Number: 1020279-2017-00192
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• 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; Required Intervention