MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMPERION STEM; HIP IMPLANT

Device Problems Fracture (1260); Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/14/2013

Event Type  Injury  

Event Description

It was reported that the surgeon experienced difficulty impacting the stem into final position due to an overhang of the greater trochanter, which impeded it's insertion.He continued to impact the stem (via a stem inserter instrument) and initiated a femoral fracture.Following the final seating of the stem, the patient's femoral fracture was addressed with cables.

Manufacturer Narrative

This event has been evaluated by our medical advisor.This evaluation determined that if left untreated, this fracture does not heal spontaneously and may cause a permanent damage both from an anatomic as well as bio-mechanic point since the greater trochanter is the point of insertion of the abductor muscles which allow stability and correct functioning of the hip joint.The condition of the prominence of the greater trochanter should have been addressed during femoral broaching.The risk of femoral fracture is spelled out in both the ifu and surgical technique, stating "congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, patient non-compliance, etc.Can increase risk of femoral or pelvic fractures.".

• Brand Name: EMPERION STEM
• Type of Device: HIP IMPLANT
• 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: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 3654240
• MDR Text Key: 16057784
• Report Number: 1020279-2014-00123
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• 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?: No
• Date Manufacturer Received: 11/14/2013
• 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): Required Intervention