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

Model Number 71434465

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).(b)(6).

Event Description

It was reported that, during the final tightening of the hk bolt of a tka, when using the legion hinge tibial stabilizing tool in combination with the torque wrench, the small tooth on the stabilizing tool that locks inside the hk baseplate snapped off.The piece that broke away was left trapped inside the baseplate.Surgery was resumed, without any delay, with the same device.The current health status of the patient is unknown.

Manufacturer Narrative

Results of investigation: the device was returned for evaluation.A visual inspection confirms the peg broke off the device.The broken piece was not returned with the device.The device shows significant signs of wear/usage.The contribution of the device to the reported event could not be corroborated.A medical investigation was conducted and confirms without the requested documentation/information, the reported event could not be further assessed.The material composition is 17.4ph ss.The externally communicating device is neither manufactured nor intended for implantation; and is not approved for long term internal tissue exposure and long term implantation data is not available.The patient impact beyond the reported device breakage/retained foreign body (peg in the tibial baseplate) during the hk-tka procedure could not be definitively determined.Although unlikely, the potential for corrosion and local irritation/migration of the (stabilizing tool peg ) fragment could not be ruled out.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this product and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LEGION HINGE TIBIAL STABILIZING TOOL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12734082
• MDR Text Key: 279542861
• Report Number: 1020279-2021-07758
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556033098
• UDI-Public: 00885556033098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71434465
• Device Catalogue Number: 71434465
• Device Lot Number: 13HEM0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other