MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 71291302

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 06/25/2018

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to a 10 year post op emperion stem fractured.Revised stem, sleeve, reflection xlpe liner and ox head.

Manufacturer Narrative

The associated emperion stem, liner and oxinium head were returned and evaluated.It was reported that an emperion stem fractured 10 years post implantation.A lab analysis conducted during this investigation noted that the stem was fractured in the proximal sleeve taper region; radial lines were observed on the fracture, along with signs of fretting on the lateral side of the proximal taper region of the stem.The crack initiated most likely in the lateral region of the stem.Bone ongrowth was observed on the porous coated regions of the sleeve.Scratching and damage was observed on the porous coated regions of the sleeve and the distal tip of the stem that likely occurred during removal of components.Small scratches and damage were found on the liner and head that likely occurred during removal.The analysis showed that the emperion stem fractured likely due to fatigue.No defects in material or manufacturing were found during the course of this evaluation.A clinical evaluation noted that no supporting patient information or medical records were provided for review and inclusion to this investigation.The patient¿s current condition remains unknown.A review of the manufacturing records for the stem did not reveal any deviation from the standard manufacturing processes.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: EMP 13 STEM PRIMARY HO
• 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
• MDR Report Key: 7702509
• MDR Text Key: 114427056
• Report Number: 1020279-2018-01324
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K042127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2017
• Device Catalogue Number: 71291302
• Device Lot Number: 07DM14939
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 06/25/2018; 06/25/2018; 06/25/2018
• Supplement Dates FDA Received: 11/07/2018; 01/29/2019; 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4); REF XLPE 71333335 LOT 07CM21536
• Patient Outcome(s): Hospitalization; Required Intervention