MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMPERION 11 STEM PRIMARY SO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 71291101

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); No Code Available (3191)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a revision surgery was performed to remove a fractured stem.

Manufacturer Narrative

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

• Brand Name: EMPERION 11 STEM PRIMARY SO
• 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 ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6419525
• MDR Text Key: 70408167
• Report Number: 1020279-2017-00195
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K042127
• 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: 09/25/2017

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
• Device Catalogue Number: 71291101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• 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