MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR NP FEM SZ 5 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71423215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2021, the patient had an infection.A revision surgery was performed on (b)(6) 2022 where the patient had a knee washout and all the implants were removed.The current health status of the patient is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, analysis could not be performed.The clinical/medical investigation concluded that, the provided intra-op explant photos and copy of pre-revision x-ray imaging were assessed; however, do not provide insight into the root cause of the reported infection.It was communicated that the remaining clinical documentation was not available.Without the requested clinical documentation, possible contributing clinical factors could not be definitively concluded, and the source of the reported infection cannot be concluded.The patient impact beyond the reported infection and subsequent total knee revision cannot be determined.No further medical assessment could be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral component, 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 rest of the components, the review of complaint history revealed a similar event for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, 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 acute post-surgical wound infection has been identified in possible adverse effects.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 this products and event.A review of the sterilization records revealed that all the batches were sterilized within normal parameters.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 a post-surgery injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.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 CR NP FEM SZ 5 RT
• 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: 16432257
• Report Number: 1020279-2023-00403
• Device Sequence Number: 16799778
• Product Code: JWH
• UDI-Device Identifier: 00885556030158
• UDI-Public: 00885556030158
• 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: 2021
• Device Explanted Year: 2022
• 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): 03/24/2023

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: 71423215
• Device Catalogue Number: 71423215
• Device Lot Number: 21CM21360
• 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: 03/23/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GNS II CMT TIB SIZE 5 RIGHT, LOT#:21AB01334; GNS II RESURF PAT 35MM, LOT#: 21CB01923; LGN CR HIGH FLEX XLPE SZ 5-6 11MM, LOT#:21AM18459
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown