MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 18MM BOLT - SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421631
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646); Subluxation (4525); Metal Related Pathology (4530)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on an unknown date, the coupling mechanism on a lgn hk axle sz 4 femur fractured.This adverse event was addressed by performing a revision surgery on (b)(6) 2024, in which the whole legion hinge system was replaced.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Additional Manufacturer Narrative
Section h10: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the legion hinge link assembly.The device was not returned for evaluation; therefore, a device analysis could not be performed.However, the photographs were reviewed and revealed that the legion hinge link fractured off into two separate pieces.Additionally, the device's post bushing is highly deformed and fractured on one side.A review of the production order 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 device.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.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.According with the material specification, the quality and manufacture of cobalt-chromium alloy shall be controlled.This material can be used for surgical implants and can be considered surgical grade.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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.Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on an unknown date, the coupling mechanism on a lgn hk link assy sz 2-5 fem fractured.This adverse event was addressed by performing a revision surgery on (b)(6) 2024, in which the whole legion hinge system was replaced.Patient's current health status is unknown.
Additional Manufacturer Narrative
H2: additional information ¿b5, d1/d2a/d2b, d4, d10, g4, h6: health effect - clinical code¿.
Event or Problem Description
It was reported that, after a third-revision tka had been performed on (b)(6) 2019, patient experienced fracture of the coupling element due to inserted axis-couple ktep and synovitis as well metallosis on right knee.This adverse event was addressed by performing a revision surgery on (b)(6) 2024, in which the whole legion hinge system was replaced.Patient's current health status is unknow.
Additional Manufacturer Narrative
B5: corrected.
Event or Problem Description
It was reported that, after a third-revision tka had been performed on (b)(6) 2022, patient experienced fracture of the coupling element due to inserted axis-couple ktep and synovitis as well metallosis on right knee.This adverse event was addressed by performing a revision surgery on (b)(6) 2024, in which the whole legion hinge system was replaced.Patient's current health status is unknow.
Additional Manufacturer Narrative
D4 has been updated.
Additional Manufacturer Narrative
Additional information: d6a.Corrected data: h6 (health effect - clinical code, type of investigation, investigation findings).Updated results of investigation: the associated devices were returned and evaluated.The retrieved lgn hk 18mm bolt and sleeve, lgn hk axle sz 4 femur, and lgn hk gm insert 18mm sz 2-3 rt were examined using visual and macroscopic and microscopic methods.Visual examination showed fracture of the link component and extraction damage and discoloration on the lgn hk gm insert.Extraction damage can be created by the removal instrumentation used during the extraction of the implant.Also, delamination was observed on the lgn hk gm insert, axle bushing, post bushing, and the two axle stop components.The axle bushing remains assembled in the link component.The post bushing is fractured on one side.Macroscopic/microscopic examination showed wear on the articular and bottom surface of the lgn gm insert and on the hyperextension stop component.No damage was observed on the post sleeve, post bolt, and axle components.No additional unexpected visual features noted.No evidence of deviation in processing or material was found for the retrieved items.Destructive testing was not performed during this examination.No definitive conclusions as to the cause of the reported complaint can be determined.The clinical/medical investigation concluded that a definitive clinical root cause could not be determined; however, the pre-revision x-ray finding of the unknown duration of a ¿previously described loosened screw on the dorsal tibial plateau is increasingly dislocated¿ most likely contributed to the event and suggests function may have been compromised over a length of time/allowing micro-motion.The radiological finding of ¿constant whitening hems (swelling seams) between palacos and bone in the proximal tibia¿ is suspicious for an altered bone/cement interface which could potentially allow micro-motion, as well.Additionally, involvement of the re-inserted polyethylene insert and the post-operative overextension noted during the (b)(6)2022 implantation cannot be ruled out as potential contributing factors.The patient impact includes the revision with synovectomy (with evidence of abbreviated material), adhesion lysis, instability, subluxation phenomena with increasingly dislocated tibial screw, broken coupling mechanism, synovitis/synovectomy, metallosis and suspicious radiological findings.The patient's current health status and prior activity are unknown but ¿discharged home in good general condition".A review of the production order 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 device.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.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 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 18MM BOLT - SLEEVE
• 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: 19074011
• Report Number: 1020279-2024-00708
• Device Sequence Number: 4657407
• Product Code: KRO
• UDI-Device Identifier: 00885556414873
• UDI-Public: 885556414873
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2026
• Device Model Number: 71421631
• Device Catalogue Number: 71421631
• Device Lot Number: 17LBP0048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 05/02/2024; Not provided; Not provided; Not provided; 10/17/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/17/2024; 09/05/2024; 10/03/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• 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: LEGION HK GD MOTION ISRT 18MM SZ 2-3 RT; LGN HK 18MM BLT SLV(PN:71421388,LN:23BTM0004B); LGN HK 18MM BLT SLV(PN:71421388,LN:23BTM0004B); LGN HK AXLE PLUG(PN:71421932,LN:21KM16116); LGN HK AXLE PLUG(PN:71421932,LN:21KM16116); LGN HK AXLE SZ 4 FEMUR; LGN HK AXLE SZ 4 FEMUR (PN:71421935,LN:18KTM0004); LGN HK HPXT STP W/X PLG(PN:71421648,LN:19AM20698A); LGN HK HPXT STP W/X PLG(PN:71421648,LN:19AM20698A); LGN HK ISRT 18MMSZ2-3 RT(PN:71423348,LN:15EM07252); LGN HK ISRT 18MMSZ2-3 RT(PN:71423348,LN:15EM07252); LGN HK LK ASS SZ2-5FEM(PN: 71421631,LN: 21JM11239)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female