MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN DD XLPE INS W/ JRNY LOCK SZ 7-8 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71425391
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Post Operative Wound Infection (2446)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: case (b)(4).
Event or Problem Description
It was reported that, after right tka surgery had been performed on (b)(6) 2023.For the clinical study: porous tka, the patient experienced erythema.This adverse event was treated by aspiration to evaluate for infection and oral antibiotics on (b)(6) 2023.On (b)(6)2023, patient was taken to the operating room to perform a washout and poly exchange.Patient was not recovered.
Additional Manufacturer Narrative
Additional information: d10.H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a right insert revision with washout was performed on the study patient approximately 5½ weeks post implantation after patient presented twice within a week for erythema, aspirate for infection, and oral antibiotics with worsening of symptoms.The adverse event form documents this severe, ongoing adverse event as possibly related to the study device, definitely related to the study procedure, with a start date as of (b)(6) 2023 and discharge date of (b)(6) 2023.The patient outcome/adverse event was documented as ongoing, not recovered/resolved as of (b)(6) 2023.Post-op wound infection is a known possible risks with any surgical procedure and is not indicative of a malperformance of the component(s).The patient impact beyond the reported infection, provided interventions and insert revision could not be determined.No further medical assessment is warranted 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 insert and the tibial baseplate, 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 devices did not reveal similar events for the listed devices.For the femoral component, a review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch 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 system revealed that acute post-surgical wound infection, late deep wound sepsis, and/or low-grade synovitis has been identified in possible adverse effects.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.A review of the sterilization records revealed 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 loss of sterility during procedure, post-operative healing issue, 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.D9: date should have been left as blank (no device available to be return).

• Brand Name: LGN DD XLPE INS W/ JRNY LOCK SZ 7-8 12MM
• 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: 17022104
• Report Number: 1020279-2023-01198
• Device Sequence Number: 17874602
• Product Code: JWH
• UDI-Device Identifier: 00885556733776
• UDI-Public: 885556733776
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 71425391
• Device Lot Number: 21FM07067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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: 71425217/LGN POR CR HA FEM SZ 7 RIGHT; 71425307/POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 RT; PARTIAL REVISION RIGHT SIDE ON (B)(6) 2023: REPLAC; PARTIAL REVISION RIGHT SIDE ON (B)(6) 2023: REPLAC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 88 KG