MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PRSTHSIS,KNEE,PTLLOFMOROTIBIAL,SMI-CNSTRNED, CEMENTED, POLYMER/METAL

Catalog Number	74027271
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to infection.Femoral component and insert were replaced.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, it was communicated that the revision was performed due to infection.No further information or clinically relevant documentation was provided, therefore a thorough medical investigation could not be performed and the root cause of the infection remains unknown.The patient impact beyond the revision procedure, likely antibiotic therapy and the expected post-op convalescence cannot be determined.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Product was sterilized according to sterilization release documentation from quality control.No further clinical/medical investigation is warranted at the 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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM
• Common Device Name: PRSTHSIS,KNEE,PTLLOFMOROTIBIAL,SMI-CNSTRNED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7875137
• Report Number: 1020279-2018-01802
• Device Sequence Number: 1263230
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• 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: 2016
• 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): 01/15/2019

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: 06/14/2026
• Device Catalogue Number: 74027271
• Device Lot Number: 16FM13129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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: 71420568/15MM0150674022217/15MM01335
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70