MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71423358

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 07/15/2023

Event Type  Injury  

Event Description

It was reported that, after a left tka had been performed on an unknown date, the patient experienced unstable internal hinge components due to a large varus/valgus thrust.A first revision surgery was performed on (b)(6) 2023 to address this adverse event, in which one (1) legion hk gd motion isrt 18mm sz 4-5 lt, one (1) legion hk 18mm bolt ¿ sleeve, one (1) lgn hk axle sz 5 femur, one (1) lgn hk link assy sz 2-5 fem, one (1) legion hinge axle plug and one (1) legion hinge hyperextension stop with axle plugs were explanted.

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the legion motion insert.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a first left hinge knee revision was performed on (b)(6) 2023 due to patient experienced unstable internal hinge components secondary to a large varus/valgus thrust after an unknown length of time in-vivo.It was communicated that the revision implants ¿replicated ones extracted as the femoral and tibial components were stable¿.Electronic photocopied undated/unidentified x-ray images appear to show an intact left hinge knee; however, no comparison imaging was provided the root cause as well cannot be identified.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Reportedly, the revision was possibly due to ligament laxity or component wear as a large varus/valgus thrust was reported.The patient impact was the reported laxity, unstable hinge knee components and subsequent revisions.Transient post-surgical phases would be anticipated.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that varus-valgus deformity is a possible adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, 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: 18591186
• MDR Text Key: 333895641
• Report Number: 1020279-2024-00235
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556030813
• UDI-Public: 00885556030813
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: 71423358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2023
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71421388/LEGION HK 18MM BOLT - SLEEVE; 71421631/LGN HK LINK ASSY SZ 2-5 FEM; 71421648/LGN HK HYPEREXT STOP W/AX PLUG; 71421932/LGN HK AXLE PLUG; 71421936/LGN HK AXLE SZ 5 FEMUR
• Patient Outcome(s): Required Intervention