MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 1-2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420959
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Implant Pain (4561)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
*legal case* it was reported that, after a prosthetic re-implant had occurred on (b)(6) 2018 with a legion knee system, the patient started experiencing pain.The x-rays showed the femoral and the tibial stems with phlogosis.A revision surgery was necessary to remove the whole system and replaced it with cement spacers on (b)(6) 2021.The outcome of the patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, per complaint details, the 61yr old female required explantation of the legion knee system components approximately 3 years post-implantation due to the onset of pain, functional limitation and ¿rx showing signs of mobilization of the femoral and tibial stems with alleged phlogosis¿.Reportedly, cement spacers were used to replace the components.The requested clinical documentation (including but not limited to operative notes, x-rays and lab results) and/or the explanted components have not been provided as of the date of this medical assessment.The reported clinical root cause and patient impact beyond the reported events could not be further assessed without the requested medical documentation.Should the requested documentation become available, the medical investigation 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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use or patient reaction.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.We consider this investigation closed.

• Brand Name: LEGION CON ART INS 9MM SZ 1-2
• 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: 11806515
• Report Number: 1020279-2021-03998
• Device Sequence Number: 17055555
• Product Code: JWH
• UDI-Device Identifier: 03596010555816
• UDI-Public: 03596010555816
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420959
• Device Catalogue Number: 71420959
• Device Lot Number: D1414692
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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