MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 7-8; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER

Model Number	71420551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka was performed on an unspecified date, the patient experienced instability.This adverse event was solved by a revision surgery on an (b)(6) 2022.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a ¿poly-swap¿/revision was performed due to instability after an unspecified length of time in-vivo.Reportedly, a constrained poly was used to address the instability.The requested medical documentation has not been received as of the date of this medical investigation.The current health status of the patient remains unknown.Without the requested clinical documentation, the root cause of the reported instability could not be further assessed.The patients¿ impact beyond the reported instability and ¿poly-swap¿/revision could not be determined.No further medical assessment could be rendered at this time.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that loosening, dislocation, subluxation, excessive rotation, flexion contracture, decreased range of motion, lengthening or shortening of the leg and looseness of components have been identified as 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.Possible causes could include but not limited to fit/sizing issue, lifetime of device or patient condition.The contribution of the device to the reported event could not be corroborated.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 CON ART INS 9MM SZ 7-8
• Common Device Name: PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER
• 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: 14407147
• Report Number: 1020279-2022-02379
• Device Sequence Number: 14108191
• Product Code: JWH
• UDI-Device Identifier: 03596010555830
• UDI-Public: 03596010555830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 71420551
• Device Catalogue Number: 71420551
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 127 KG