MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 7 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71423227
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka surgery had been performed on (b)(6) 2016 and a washout and liner exchange had been performed 2 weeks after.A revision surgery was performed on (b)(6) 2023 because the patient presented an infection.This was a first stage revision.No devices have been implanted, other than a spacer k.No further information available at this moment.
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.A visual inspection of the images provided did not reveal any defects that would cause the reported adverse event.The clinical/medical investigation concluded that, approximately six years post washout and liner exchange, first stage of a two-stage revision due to infection was reported.A single unlabeled x-ray of the anterior left knee and a single x-ray of the patient lateral left knee do not indicate a root cause.However, no clinical information was provided for the assessment and the x-rays do not confirm the alleged infection.An infection for a device that was implanted for the prior 6 years is not an acute infection and likely hematogenously spread, therefore, it is not likely that the reported infection was associated with a mal performance of the implant or an implant failure.The impact to the patient beyond the reported infection and first stage revision cannot be confirmed nor concluded.For gns ii cmt tib size 6 {} left and legion ps np fem sz 7 lt a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For gii ps hi flex isrt sz 5-6 9 and gns ii resurf pat 35mm, device batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For gns ii cmt tib size 6 {} left and legion ps np fem sz 7 lt, 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 device did not reveal similar events for the listed devices.For gii ps hi flex isrt sz 5-6 9, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For gns ii resurf pat 35mm, a review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.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.For gns ii cmt tib size 6 {} left and legion ps np fem sz 7 lt, a review of the sterilization records revealed that the batches were sterilized within normal parameters.For gii ps hi flex isrt sz 5-6 9 and gns ii resurf pat 35mm since the device batch numbers were not provided, a review of the sterilization records 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 injury, patient condition and/or medical history.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: LEGION PS NP FEM SZ 7 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: 16432145
• Report Number: 1020279-2023-00402
• Device Sequence Number: 20158079
• Product Code: JWH
• UDI-Device Identifier: 03596010611505
• UDI-Public: 03596010611505
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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 Expiration Date: 12/31/2021
• Device Model Number: 71423227
• Device Catalogue Number: 71423227
• Device Lot Number: 12AM00587
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/27/2023
• Date Device Manufactured: 01/03/2012
• 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