MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON STEM IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 10/09/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening.The echelon stem was revised and a redapt implant was placed instead.

Manufacturer Narrative

The affected complaint device was not returned for evaluation.It was reported that the surgeon performed a revision surgery due to a stem loosening.The echelon prothese was revised and a redapt was placed instead.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.The patient impact could not be determined with the available information.After repeated requests, smith & nephew has been unable to obtain device details.As device details were not made available, device history record review cannot be completed.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened and reevaluated.

• Brand Name: ECHELON STEM IMPLANT
• 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: 8028289
• MDR Text Key: 125786852
• Report Number: 1020279-2018-02327
• 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
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• 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: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention