MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW PS OXIN SZ 5N LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the patient complained of knee discomfort following a primary tka on (b)(6) 2020.Surgeon diagnosed the jointline was too high.Revision surgery was performed on (b)(6) 2023, to replace one (1) gns ii con ins sz 3-4 15mm and one (1) legion narrow ps oxin sz 5n lt.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, patient-specific clinical documentation has not been received.Without the requested medical documentation, definitive clinical factors which could have contributed to the reported event could not be concluded.Reportedly, the root cause of the revision was diagnosed as ¿the joint-line was too high¿ which does not support any component mal-performance.The patient outcome beyond that which was reported could not be determined.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors.Besides, preoperative planning and meticulous surgical technique are essential to achieve optimum results.Considerations of anatomic loading, soft-tissue condition, and component placement are critical to minimize a variety of postoperative complications.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 patient condition and/or healing factors.Based on this investigation, the need for corrective action is not indicated.Should the devices a 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 NARROW PS OXIN SZ 5N LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 16415114
• Report Number: 1020279-2023-00387
• Device Sequence Number: 3504662
• Product Code: JWH
• UDI-Device Identifier: 00885556234006
• UDI-Public: 00885556234006
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 71421265
• Device Catalogue Number: 71421265
• Device Lot Number: 18JM11388
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/21/2023
• Date Device Manufactured: 09/17/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GNS II CON INS SZ 3-4 15MM, LOT#:17HM18506
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown