MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 LT 9MM; PRSTHSIS,KNEE,PATLLFMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	74027221
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Insert was replaced.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Product was sterilized according to sterilization release documentation from quality control.Our clinical/medical team concluded that insufficient clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was communicated that due to infection, the insert component was revised approximately 3 weeks post tka.No further clinically relevant documentation and/or information were provided, therefore the root cause of the reported infection remains unknown.The patient impact beyond the revision/poly exchange for infection, probable additional antibiotic therapy, and an expected post op convalescence period cannot be determined.No further medical assessment is warranted at this time.Without the actual product involved, 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.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 LT 9MM
• Common Device Name: PRSTHSIS,KNEE,PATLLFMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7915046
• Report Number: 1020279-2018-01797
• Device Sequence Number: 16522558
• Product Code: JWH
• UDI-Device Identifier: 00885556177211
• UDI-Public: 00885556177211
• 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
• Report Date (Section B): 11/18/2018

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: No Information
• Device Expiration Date: 03/11/2018
• Device Catalogue Number: 74027221
• Device Lot Number: 18CM23579
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/18/2018
• 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