MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 11MM SZ 2-3 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71423341
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a procedure was performed on (b)(6) 2021, the patient experienced migration of the screw.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a legion hk gd motion isrt 11mm sz 2-3 lt was exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation, but the clinical investigation confirmed the screw migration.The clinical/medical investigation concluded that based on the limited documentation provided, no clinical factors have been identified which would have contributed to the reported event; however, the provided x-ray image confirms the backed out screw as well as the appearance of tibial baseplate radiolucencies.It is unknown if the surgical technique was adhered to in regard to lock screw/torque/wrench calibration.The current patient status is unknown, and it is unknown if the noted radiolucencies were stable.The patient impact includes the screw migration and revision surgery along with an anticipated recovery phase.No further patient impact can be determined.No further medical assessment can be rendered at this time.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 reveal that improper fixation, and/or migration of the components could cause possible adverse effects.Also, the warnings and precautions section establish that the implant can become damaged as a result of strenuous activity or trauma.The patient should be warned of surgical risks, and made aware of possible adverse effects.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 reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, alignment, size selected, patient anatomy, procedural/user error and/or traumatic injury.The contribution of the device to the reported incident could be corroborated as it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 11MM SZ 2-3 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: 15882633
• Report Number: 1020279-2022-04853
• Device Sequence Number: 14781420
• Product Code: KRO
• UDI-Device Identifier: 00885556031087
• UDI-Public: 00885556031087
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 12/26/2022

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 Model Number: 71423341
• Device Catalogue Number: 71423341
• Device Lot Number: 18MM07142
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown