MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 13MM X 160MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	71424046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tkr revision surgery had been performed on an unknown date, the patient experienced range of motion issues, presenting loose extension and tight in flexion.A revision surgery was performed on (b)(6) 2023 to address this adverse event.The femoral component, the tibial base plate, stem and the tibial insert were explanted.Legion revision tibia and femur were implanted with femoral distal wedges and a constrained poly insert.It is unknown current health status of patient.
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, per case details, after a tka revision surgery was performed, the patient reportedly ¿experienced range of motion issues, presenting loose extension and tight in flexion.¿ additionally, a subsequent revision and explantation of components (the tibial base plate, stem and the tibial insert were explanted/replaced with a legion revision.As of the date of this medical investigation, the requested clinical documentation including surgical/operative report has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported symptoms and revision cannot be determined and the patient¿s current health status is unknown.Therefore, no further clinical/medical assessment can be rendered.Should additional clinically relevant information/documentation become available, the clinical/medical task may be re-opened for further evaluation.For lgn pressfit stem 13mm x 160mm, 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 revealed in possible adverse effects that decreased range of motion and unusual stress concentrations can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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.For legion total knee rev fem comp, genesis ii total knee tib baseplate and genesis ii total knee tib insert, device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.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 alignment, size selected or wear.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: LGN PRESSFIT STEM 13MM X 160MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 16325767
• Report Number: 1020279-2023-00302
• Device Sequence Number: 15614604
• Product Code: JWH
• UDI-Device Identifier: 03596010546784
• UDI-Public: 03596010546784
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71424046
• Device Catalogue Number: 71424046
• Device Lot Number: 20LSM0192
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown