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

Catalog Number 71342012

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that a revision surgery has occurred.X-rays showed fracture of echelon stem and then this was revised.

Manufacturer Narrative

The associated complaint device was not made available for evaluation.The source of the information is a literature document and after investigating, smith and nephew cannot obtain enough information about the patient and/or device mentioned.What is known is that this patient was a 71-year-old woman that had a left total hip replacement, revised in 2007 for aseptic loosening.She is bilateral implantee.The device is identified to be a 12mm echelon stem.Which specific stem it is cannot be ascertained.The authors review of the attached radiograph indicates a fracture of the stem with an obvious non-union of the extended trochanteric osteotomy and severe osteolysis under the stem collar.The author commented that a non-union of the extended trochanteric osteotomy compromised the proximal bone support.The author further states that the mechanism of failure would be cantilever forces generated by a weak proximal support.It was noted in the article that the patient continues to do well on ongoing follow-up.In order to provide a complete report against this reportable event numerous attempts were made to identify the device to no avail.A review of complaint history was limited, as the device has not been identified.A review of relevant clinical/medical information in the reported issue is inconclusive.No information concerning patient information, surgical procedure/post-operative care review, device labeling has been provided or received.The physician referenced in the abstract provided an analysis of all of the attached x-rays, therefore, no further clinical interpretation of the x-rays is required.No further clinical/medical assessment is warranted at this time.Without identifying the actual product involved and/or device information, our investigation is inconclusive as to the direct cause for the event.If the device or new information is received in the future, this complaint will be re-opened.

• Brand Name: ECHELON STEM
• 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: 7985802
• MDR Text Key: 124374551
• Report Number: 1020279-2018-02231
• 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: 03/27/2019

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 Catalogue Number: 71342012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 09/26/2018; 09/26/2018
• Supplement Dates FDA Received: 02/14/2019; 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention