MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD LT SZ 5-6 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74025764
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a journey ii poly was explanted from a patient as part of an irrigation and debridement process for periprosthetic knee infection.The explanted poly was replaced by another poly of the same type.The poly was not considered to be the problem.The original primary tka procedure was performed on (b)(6) 2020.The outcome of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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 case reports a poly exchange during an irrigation and debridement, due to infection.To date, the requested surgical reports and x-rays have not been provided.Therefore, the patient impact beyond the reported infection and revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation become available, this clinical/medical task may be re-opened.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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, 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 ISRT XLPE DD LT SZ 5-6 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10542141
• Report Number: 1020279-2020-04621
• Device Sequence Number: 3124326
• Product Code: JWH
• UDI-Device Identifier: 00885556098561
• UDI-Public: 00885556098561
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K113482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: Health Professional
• Device Model Number: 74025764
• Device Catalogue Number: 74025764
• Device Lot Number: 18BM02338
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 06/30/2021
• 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