MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMPERION STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 02/17/2017

Event Type  Injury  

Event Description

It was reported that the stem fractured above the sleeve and that a revision surgery has been scheduled.

Manufacturer Narrative

We have received information that the event reported through this mdr represents a duplication of another event captured in our system and reported under mdr 1020279-2017-00158.We shall close the duplicate entry and ask you to disregard mdr 1020279-2017-00141.

• Brand Name: EMPERION STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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 ; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6367337
• MDR Text Key: 68596633
• Report Number: 1020279-2017-00141
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention