MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 5-6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420537
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery had to be perform due to posterior subluxation of the femur from the tibia in a particular range of motion.Upon further examination, the surgeon was able to conclude that the poly insert had become disassociated from the tibial tray.No further issues during the revision.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is heavily damaged from wear, extraction and the disassociation from the tibial base.The device was manufactured in 2019.A dimensional inspection was attempted but the device was too damaged to obtain accurate measurements.The lab analysis concluded that the returned legion insert was examined visually.There were signs of deformation along the anterior rim, which was may have been sustained during insertion or removal of the device.There were signs of wear on the articulating surface of the insert.Signs of deformation and wear were observed on the posterior region of the insert post.The anterior and posterior non-articulating surfaces of the insert had signs of burnishing and deformation indicating the insert was disassociated from the baseplate.This observation was consistent with the reported complaint of a disassociated insert.Signs of abnormal deformation of the anterior locking mechanism indicated the insert was likely never fully seated in the tibial baseplate.Signs of gouging and deformation were observed on the anterior toe region of the insert post likely due to contact with the trochlear groove region of the femoral component while the insert was tilted posteriorly.Deformation was observed on the inclined surface of the superior/anterior region of the insert.No manufacturing deviations were observed during this investigation.The clinical/medical evaluation concluded that based on the documentation provided, the root cause of the revision was the insert dislocation; although the root cause of the dislocation could not be definitively concluded.Early post-op dislocations may be seen when the primary insert was not completely locked into the baseplate, excessive joint laxity, lack of post-operative restrictions, and/or post trauma.The patient impact beyond the reported ¿posterior subluxation¿/disassociation and subsequent revision could not be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 future complaints and investigate as necessary.

• Brand Name: LEGION CON ART INS 9MM SZ 5-6
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10356017
• Report Number: 1020279-2020-03635
• Device Sequence Number: 11362534
• Product Code: JWH
• UDI-Device Identifier: 03596010555809
• UDI-Public: 03596010555809
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 71420537
• Device Catalogue Number: 71420537
• Device Lot Number: 19KT29599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention