MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE TIBIAL STABILIZING TOOL; PROSTH, KNEE, PAT/FEMORTIB, SEM-CONSTRAIN, UNCMNT, PORUS, COAT, POL/MET/POL

Catalog Number 71434465

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to change the poly on the hinged knee.During the procedure, the tooth of the stabilizing tool broke within the patient.All pieces were removed.The procedure was finished with a smith and nephew backup.There was no delay in the case.

Manufacturer Narrative

Results of investigation: it was reported that a revision surgery was performed to change the poly on the hinged knee.There was nothing wrong with the poly, the doctor just wanted to reduce the joint line.During the procedure, the tooth of the stabilizing tool broke within the patient.All pieces were removed.The procedure was finished with a smith and nephew backup.There was no delay in the case.The affected complaint device, used in treatment, was not returned for evaluation.However, a picture was provided which confirmed the stated failure.A piece of metal has broken off of the device.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the device failed to meet specifications.Based on this investigation, the need for corrective action is not indicated.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of risk management files found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.This part was manufactured in 2012 and this device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.We consider this investigation closed.

• Brand Name: LEGION HINGE TIBIAL STABILIZING TOOL
• Type of Device: PROSTH, KNEE, PAT/FEMORTIB, SEM-CONSTRAIN, UNCMNT, PORUS, COAT, POL/MET/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10129435
• MDR Text Key: 194357052
• Report Number: 1020279-2020-02157
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556033098
• UDI-Public: 885556033098
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71434465
• Device Lot Number: 12FEM0002
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention