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

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Revision surgery of right hip femoral stem and acetabular component was performed due to stem fracture.Devices implanted during 2009 at an unknown location in texas.The patient experienced increasing pain and reported to a hospital, whereby x-rays showed a fractured stem.Significant polyethylene wear reportedly noted and lightly retroverted acetabular component.Trochanteric osteotomy required to remove stem.

• Brand Name: EMPERION FEMORAL 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 odoy ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 5986197
• MDR Text Key: 55877187
• Report Number: 1020279-2016-00759
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ACETABULAR COMPONENT, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 91