MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 15MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027236
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to superficial infection.Insert and patellar component were replaced.The surgeon does not blame the products.
Additional Manufacturer Narrative
Additional information: concomitant medical products.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and insufficient clinically relevant supporting documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was reported that the surgeon did not fault the components , as the superficial infection was the cause for the revision of the poly insert and patellar component.The patient impact beyond the revision procedure, treatment for the reported infection and an expected brief post-op rehabilitation phase cannot be determined.No further medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 15MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8218063
• Report Number: 1020279-2019-00051
• Device Sequence Number: 10814823
• Product Code: JWH
• UDI-Device Identifier: 00885556179260
• UDI-Public: 00885556179260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2019

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: 09/17/2026
• Device Catalogue Number: 74027236
• Device Lot Number: 16JM08670
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 12/16/2018; 12/16/2018
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/15/2019; 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022114/18GM1113374022214/18EM12668
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention