MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK AXLE SZ 5 FEMUR; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421936
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka-revision surgery had been performed on 2016, the patient experienced knee instability.Surgeon thought it could be an axle failure.Modular implants were removed per technique on the femur.The axle did not appear to be bent and the hinge link assembly did not appear damaged either.This adverse event was addressed by a second-revision surgery on (b)(6) 2023, in which they exchange the following devices: lgn hk axle sz 5 femur, legion hk 11mm bolt - sleeve, lgn hk hyperext stop w/ax plug, lgn hk link assy sz 2-5 fem and legion hk gd motion isrt 11mm sz 4-5 lt.After procedure, surgeon was satisfied with stability.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a second total knee arthroplasty revision was performed approximately 7 years post first revision due to knee instability.Reportedly, the surgeon thought it could be an axle failure and modular implants were removed per technique on the femur; however, the axle did not appear to be bent and the hinge link assembly did not appear damaged.The surgeon was reportedly satisfied with stability post revision which included the femoral axle, bolt-sleeve, hyperextension stop, axle plugs, link assembly and motion insert; however, the requested medical documentation/further information is unknown and not available.The patient's current health status remains unknown and a clinical root cause for the instability cannot be concluded.Patient impact beyond the reported instability and second revision cannot be determined based on the limited information provided.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the legion axle femur, hinge hiperextension and hinge link, 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 the bolt-sleeve and insert, a review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 looseness 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.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include joint laxity, patient condition 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.

• Brand Name: LGN HK AXLE SZ 5 FEMUR
• 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: 18229810
• Report Number: 1020279-2023-02347
• Device Sequence Number: 5531723
• Product Code: KRO
• UDI-Device Identifier: 00885556031124
• UDI-Public: 00885556031124
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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 Expiration Date: 12/21/2018
• Device Catalogue Number: 71421936
• Device Lot Number: 08FTM0009A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2008
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71421385 / LOT: 16ATM0002C; PN: 71421631 / LOT: 13KPB0080A; PN: 71421648 / LOT: 15BM10372; PN: 71423352 / LOT: 15DM04981
• Patient Age: 72 YR
• Patient Sex: Male