MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 RT 18M; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74029237
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka procedure, patient had their knee washed out because of suspected infection.The poly was swapped out for a new one.No delay to procedure.
Additional Manufacturer Narrative
Additional information: the associated complaint device was returned and evaluated.A lab analysis was conducted and the component was inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The articulating surface of the insert showed minimal wear.The insertion/extraction slot was deformed, likely due to removal.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical evaluation was conducted and this case reports that after a tka procedure the patient had their knee washed out because of suspected infection.The poly was swapped out for a new one.Per product evaluation the insertion/extraction slot was deformed, likely due to removal, there were no observations of material or manufacturing deviations during the course of the product investigation.It has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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.Should information become available this complaint can be re-assessed.Available this complaint can be re-assessed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II BCS CNSTRD ART ISRT 3-4 RT 18M
• 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: 8491895
• Report Number: 1020279-2019-01451
• Device Sequence Number: 16525096
• Product Code: JWH
• UDI-Device Identifier: 00885556174715
• UDI-Public: 00885556174715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Catalogue Number: 74029237
• Device Lot Number: 17CM01676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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