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
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a left tka revision surgery was performed on (b)(6) 2023, the legion hinge construct became unstable after a few months of being implanted.Surgeon suspects that the legion hk gd motion isrt 18mm sz 4-5 lt was undersized and positioned loose, as the thickness of the poly was upsized during the second revision performed on (b)(6) 2023 and the construct was very stable after implantation.Patient is doing well with the revised implants.
Additional 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.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The visual inspection revealed devices does not reveal any defects.However, the post bushing edge of the hinge link assy is fractured.According to the client communication this occurred during the extraction and it was not fracture before the revision.The clinical/medical investigation concluded that, reportedly, both left revisions were due to unstable internal hinge components with the first revision possibly due to ligament laxity or component wear as a large varus/valgus thrust was reported.The second revision was most likely due to the suspected undersized component as ¿upsized (to a 21mm thickness) during the second revision performed on (b)(6) 2023 and resulted in a ¿very stable¿ construct with patient doing well post second revision.The patient impact was the reported laxity, unstable hinge components and subsequent revisions.Transient post-surgical phases would be anticipated.A review of the production orders for the insert and hinge link assy did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that reveals in the intraoperative section that the correct selection of the implant is extremely important.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include user error, surgical/extraction technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should 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.
Additional Manufacturer Narrative
Updated results of investigation: the associated devices were returned and evaluated.The visual inspection does not reveal any defect with the reported articular insert.The post bushing edge of the hinge link assy is fractured.Based on the information provided this occurred during the extraction and it was not fracture before the revision.The clinical/medical investigation concluded that, reportedly, both left revisions were due to unstable internal hinge components with the first revision possibly due to ligament laxity or component wear as a large varus/valgus thrust was reported.The second revision was most likely due to the suspected undersized component as ¿upsized (to a 21mm thickness) during the second revision performed on (b)(6) 2023 and resulted in a ¿very stable¿ construct with patient doing well post second revision.The patient impact was the reported laxity, unstable hinge components and subsequent revisions.Transient post-surgical phases would be anticipated.A review of the instructions for use documents for knee systems revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.A review of the risk management files 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 these products and event.For the hyperextension stop, the batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 15 months revealed similar events for this device, this failure mode will be monitored for future complaints for any necessary corrective actions.For the rest of the devices, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the insert and bolt & sleeve components, a review of complaint history revealed a single similar event for the each device over the previous 15 months, but no similar events for the batches based on the historical data.For the axle and link assembly, the complaint history review revealed similar events for the over the previous 15 months, but no similar events for the batches.This failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include user error, surgical/extraction, technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should 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
• Common Device Name: 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: 18591346
• Report Number: 1020279-2024-00236
• Device Sequence Number: 6858335
• Product Code: KRO
• UDI-Device Identifier: 00885556030813
• UDI-Public: 00885556030813
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71423358
• Device Lot Number: 21CM23177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 03/14/2024; 10/28/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/18/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421388/LEGION HK 18MM BOLT - SLEEVE; 71421631/LGN HK LINK ASSY SZ 2-5 FEM; 71421648/LGN HK HYPEREXT STOP W/AX PLUG; 71421936/LGN HK AXLE SZ 5 FEMUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown