MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 12MM X 160MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71424045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthralgia (2355)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tibial revision surgery performed approximately 3 to 5 years ago, the patient experienced stiffness and tibial pain.Another revision surgery was performed on (b)(6) 2023 to address this adverse event, replacing with another legion revision and shorter tibial stem.Current health status of patient is unknown.
Additional Manufacturer Narrative
H10: 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, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.According to the report, a 2nd revision was performed on 9-4-2023, to address the reported stiffness and tibial pain, by replacing with another legion revision and shorter tibial stem.However, the patient¿s outcome is unknown.Therefore, the patient impact beyond that which has already been reported cannot be confirmed nor concluded.For the lgn offset coupler a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the lgn pressfit stem device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the lgn offset coupler 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.For the lgn pressfit stem a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For all the devices 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.For the lgn pressfit stem and lgn offset coupler a review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.For the lgn pressfit stem and lgn offset coupler a historical review concluded that there are no prior actions related to these products and event.For the unkn legion total knee rev tibial baseplate and unkn legion total knee rev tibial insert uhmwpe devices specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, 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 traumatic injury, joint tightness, patient condition, alignment 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 12MM X 160MM
• 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: 17824644
• Report Number: 1020279-2023-01852
• Device Sequence Number: 12302484
• Product Code: JWH
• UDI-Device Identifier: 03596010546777
• UDI-Public: 03596010546777
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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 Catalogue Number: 71424045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown