MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE TIBIAL STABILIZING TOOL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLY

Catalog Number 71434465

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

It was reported that while tourquing down the bolt & nipple broke off and snapped.All pieces retrieved nothing left in patient.No delay happened at end of surgery.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned legion hinge tibial stabilizing tool confirms the stated failure.The peg is fractured from the tip of the device.This fragment was not returned with the complaint.Manufactured in 2012, this device exhibits signs of repeated use and significant wear.A clinical analysis indicated that during the surgical procedure the bolt & nipple broke off and snapped falling into the operative site.It was further communicated that all fragments were removed and the patient did not sustain any injuries.Since no harm to the patient is being reported, no further medical assessment is warranted.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.Should additional information be received, the complaint will be reopened.

• Brand Name: LEGION HINGE TIBIAL STABILIZING TOOL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8209076
• MDR Text Key: 131808957
• Report Number: 1020279-2019-00005
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556033098
• UDI-Public: 00885556033098
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71434465
• Device Lot Number: 12LEM0005
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR