MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 1-2 RT 9MM; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	74023811
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject suffered a case of infection in the operative side.The event was resolved via both liner exchange.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that this clinical study complaint reports that an i&d and liner exchange was performed approximately 6 weeks post-implantation, due to a periprosthetic joint infection.Per the provided documentation, the patient was put on 6 weeks of iv antibiotics following the surgery, and the outcome is reported as resolved.The device was not returned to fully evaluate the root cause of the reported events.Therefore, the patient impact beyond the revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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: JRNY II XR INS XLPE LAT 1-2 RT 9MM
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10591609
• Report Number: 1020279-2020-04907
• Device Sequence Number: 2410066
• Product Code: JWH
• UDI-Device Identifier: 00885556615515
• UDI-Public: 00885556615515
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: Lay User/Patient
• Device Model Number: 74023811
• Device Catalogue Number: 74023811
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention