MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 38 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74024838
Health Effect - Clinical Codes	Pain (1994); Joint Swelling (2356); No Code Available (3191)
Date of Event	05/02/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through clinical study that patient underwent "other conservative approach" in order to address pre-patellar effusion.Outcome was deeemed resolved on the same day and severity deemed as moderate.
Additional Manufacturer Narrative
Corrections based on new information received.
Additional Manufacturer Narrative
Study investigator has reassessed this event and has updated its description to right knee pain including pre-patellar effusion, redness, swelling.Actions take to address this are remedial therapy and other conservative approach.
Event or Problem Description
Remedial therapy involved levaquin 50mg daily x7 days and then keflex 500mg q6 hr for unknown duration.
Additional Manufacturer Narrative
The devices related to this complaint were not returned.[(b)(4)].

• Brand Name: JRNY BCS PAT RESRF RD 38 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6515171
• Report Number: 1020279-2017-00291
• Device Sequence Number: 13817639
• Product Code: JWH
• UDI-Device Identifier: 03596010554550
• UDI-Public: 03596010554550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/09/2017

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: 01/08/2022
• Device Model Number: 74024838
• Device Catalogue Number: 74024838
• Device Lot Number: 12AM06582
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 06/12/2017; 07/20/2017; 08/01/2017; 08/01/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 07/12/2017; 07/25/2017; 08/31/2017; 10/09/2017
• 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: JOURNEY TIBIA BASE NP RT SZ 5, (B)(4)/ UNK LOT; JRNY BCS II FEMORAL OXIN RT SZ 6, (B)(4)/UNK LOT; JRNYIIBCS XLPE ART ISRT SZ5-6RT10MM,(B)(4)/UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 106