MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR NP FEM SZ 8 RT; P, KNEE, PATEFEMTIB, SEMI-CONSTRAINED, CEMENTED, P/M/P

Model Number	71423218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial mdr.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, following an initial tka performed on (b)(6) 2021, the patient underwent first-stage revision surgery due to infection.An antibiotic spacer was placed as part of this procedure.All implants were revised.The patient's outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the infection.Based on the information provided, the patient underwent a first-stage revision with antibiotic spacer and all implants were revised.However, the patient¿s outcome is unknown.Therefore, it cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant or implant failure.The impact to the patient beyond that which has already been reported cannot be determined.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Should any additional relevant medical information be provided, this case would be re-assessed.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 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 file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A factor that could contribute to the reported event include patient reaction.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 8 RT
• Common Device Name: P, KNEE, PATEFEMTIB, SEMI-CONSTRAINED, CEMENTED, P/M/P
• 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: 15862875
• Report Number: 1020279-2022-04809
• Device Sequence Number: 6940384
• Product Code: JWH
• UDI-Device Identifier: 00885556030165
• UDI-Public: 00885556030165
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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: 71423218
• Device Catalogue Number: 71423218
• Device Lot Number: 21AM07640
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/24/2022
• Supplement Report FDA Received Date: 12/23/2022
• Date Device Manufactured: 01/13/2021
• 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: 71420188 / GNS II CMT TIB SIZE 6 RIGHT / 21CB01073; 71423218 / LEGION CR NP FEM SZ 8 RT / 21AM07640; 71453121 / LGN CR HIGH FLEX XLPE / 21AM18458
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown