MAUDE Adverse Event Report: SMITH & NEPHEW, INC. XR ART ISRT XLPE MED SZ3-4 RT 8MM -2DEG; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CTD, POLM/POL

Catalog Number	74023962
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
[study: journey ii xr; subject id: (b)(6); ae#: 2] it was reported that, after a tka had been performed in which a journey ii xr system was implanted, the clinical subject suffered from a (b)(6) infection.A revision surgery was performed to treat the adverse event.The event is resolved.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case from the united states and the retrospective study for journey ii cr reports the clinical subject suffered from a mssa infection.A revision surgery was performed to treat the adverse event.The event is resolved.The outcome was: resolved with the revision - subject records were updated by site, this adverse event was discovered during routine reconciliation.The clinical study report forms were provided but did not reveal a cause for the infection.The infection probably had a hematogenous root cause.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of risk management files and instructions for use found that the reported failure was documented appropriately.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.Without the actual product involved and/or device information, our investigation cannot proceed.

• Brand Name: XR ART ISRT XLPE MED SZ3-4 RT 8MM -2DEG
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CTD, POLM/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10096950
• Report Number: 1020279-2020-01877
• Device Sequence Number: 11609785
• Product Code: JWH
• UDI-Device Identifier: 00885556615980
• UDI-Public: 885556615980
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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 Expiration Date: 08/02/2026
• Device Catalogue Number: 74023962
• Device Lot Number: 16HM03325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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
• Patient Age: 27 YR
• Patient Weight: 87