MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK AXLE SZ 7 FEMUR; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71421938

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported that, after the implantation of a lgn hk axle sz 7 femur on (b)(6) 2017 on the left knee, the femur was found to be laterally loosened with an indwelling.Therefore a revision surgery had to be performed on (b)(6) 2023, where a complete femur and cone change had to be carried out after a complex explantation.A legion hk system was implanted in exchange.No other complications were reported.Patient's current health status is unknown.

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

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the provided photocopied left knee x-ray image appears to show a laterally migrated axle with radiolucencies around the femoral component and stem and between the bone and cement mantel.This could have contributed to the lateralization of the axle due to micro and/or micromotion and subsequent revision.It is unknown if the imaging was performed due to the patient being symptomatic or if this was an incidental finding.The patient impact included the noted radiolucencies, the reported axle migration/lateralization, and subsequent hk revision.The current patient status is unknown.No further medical assessment can be rendered at this time.For the legion hinge femoral axle device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the rest of the devices a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the legion hinge femoral axle a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For the rest of the devices 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.For all the devices 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 for 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 reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.Corrected data: b1 (type of event), d10 (additional concomitants added), h6 (health effect - clinical code).

• Brand Name: LGN HK AXLE SZ 7 FEMUR
• 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: 17694516
• MDR Text Key: 322778392
• Report Number: 1020279-2023-01734
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556108833
• UDI-Public: 00885556108833
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71421938
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 71421386/LEGION HK 13MM BOLT - SLEEVE.; 71422107/LGN HK DIS FEM WEDGE SZ 7 20M.; 71422168/LGN HK DIS FEM WDG SZ7 15MM.; 71423365/LEGION HK GD MOTION ISRT 13MM SZ 6-7 LT.; 71424210/LGN CEMENT STEM18MMX160MM STRT.; PART NUMBER: 71421307 / LOT NUMBER: 14CAF0008A.; PART NUMBER: 71421377 / LOT NUMBER: 15DM00876.; PART NUMBER: 71421386 / LOT NUMBER: 13KTM0014C.; PART NUMBER: 71422107 / LOT NUMBER: 14CAP2904B.; PART NUMBER: 71422168 / LOT NUMBER: 14BAP3669A.; PART NUMBER: 71423365 / LOT NUMBER: 14CM13459S.; PART NUMBER: 71424210 / LOT NUMBER: 16FSM0429A.; PART NUMBER: 71424227 / LOT NUMBER: 15KSM0164J.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male