MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ECHELON STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNKNOWN

Device Problem Crack (1135)

Patient Problems Failure of Implant (1924); Pain (1994); Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).

Event Description

It was reported that a revision surgery was performed due to a crack in stem.There is stress raised with cracks between 2 cables.The patient was doing fine, until 2 weeks ago when he complained of pain.Primary surgery was performed in 2011.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the limited information provided, the clinical root cause could not be definitively concluded; however, the radiolucency noted is consistent with poor bony support and could leave the proximal stem exposed to micromotion and ultimate stress fatigue.Also the mix-manufacturer construct could not be ruled out as a potential contributing factor to the reported events.The patient impact beyond the reported pain, stem fracture, periprosthetic fracture, and noted radiolucency and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN ECHELON STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11308669
• MDR Text Key: 231189548
• Report Number: 1020279-2021-01103
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention