MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PROSTHETIC HIP JOINT

Catalog Number 71291302

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/26/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to a fracture of the device.

Manufacturer Narrative

Manufacturer Narrative

The associated devices were returned and evaluated.The visual inspection of the devices confirms that the stem is broken.The liner shows damage not uncommon when product is removed.We were unable to perform a dimensional or functional analysis due to the damage to the devices.Our lab performed an analysis of the material characteristics and the results showed the emperion stem fracture could have occurred in the lateral region of the stem.The presence of beach marks indicates that fatigue may have been the fracture mechanism.The signs of fretting observed on the lateral side of the proximal taper region of the stem indicated repeated contact between the stem and the sleeve.The signs of scratching and damage on the porous coated regions of the sleeve could have been due to removal of the components.No defects in material or design were noted during this analysis.Our investigation could not determine a specific cause of the failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EMP 13 STEM PRIMARY HO
• Type of Device: PROSTHETIC HIP JOINT
• 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4334251
• MDR Text Key: 5141365
• Report Number: 1020279-2014-00749
• 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: Foreign,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2019
• Device Catalogue Number: 71291302
• Device Lot Number: 09KM05949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2009
• 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: 71291664/08AMB0031; 71333346/07CM13364
• Patient Outcome(s): Hospitalization; Required Intervention