MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON REVISION POROUS COATED 190MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that a patient went through a revision surgery of echelon stem due to a femoral stem fracture.

Manufacturer Narrative

The associated complaint device was not made available for evaluation.The source of the information is a literature document and after repeated requests, smith and nephew cannot obtain enough information about the patient and/or device mentioned.As device details were not made available, a device history record review cannot be completed.Also, a complaint history review could not be performed due to lack of device information.Our clinical evaluation could not be performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Per article details, the patient required revision secondary to a broken stem with morbid obesity being a possible contributing factor.The patient impact beyond the reported revision and an expected post-op convalescence phase cannot be concluded.Should additional clinical information become available in the future, the medical assessment may be re-evaluated.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: ECHELON REVISION POROUS COATED 190MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7985811
• MDR Text Key: 124374538
• Report Number: 1020279-2018-02230
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention