MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 5 RT; PRSTHSIS,KNEE,PATLLOFEMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMER

Catalog Number	74022295
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to right knee inflammation, the patient has been given medications such as vicodin and prednisone.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A clinical evaluation noted no clinical information has been provided for inclusion in this investigation.The patient currently remains in the study.No further clinical/medical assessment is warranted at this time.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Our investigation included a review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II XR BASEPLATE SZ 5 RT
• Common Device Name: PRSTHSIS,KNEE,PATLLOFEMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7705272
• Report Number: 1020279-2018-01290
• Device Sequence Number: 732927
• Product Code: JWH
• UDI-Device Identifier: 00885556615430
• UDI-Public: 00885556615430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: Health Professional
• Device Expiration Date: 07/04/2026
• Device Catalogue Number: 74022295
• Device Lot Number: 16FSL0008A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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: Other
• Patient Age: 62 YR