MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022116
Health Effect - Clinical Code	Erythema (1840)
Date of Event	05/02/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Another event occuring at similar time for the same study subject was reported under 1020279-2017-00291.Another event occuring at the same time for the same study subject was reported under 1020279-2017-00292.
Event or Problem Description
It was reported through clinical study that the subject received medication in order to address right knee redness.Severity was deemed moderate, event end date was reported (b)(6) 2012 with outcome resolved and remedial therapy given was reported to be: levaquin 50mg daily x7 days and keflex 500mg q6 hr.(b)(6) onwards.
Additional Manufacturer Narrative
A reassessment done by the study investigator of the event reported through this report concluded that multiple previously reported events represent a single occurence of an event.For this reason we consider that event reported through this report represents a duplicate of the event reported through mdr 1020279-2017-00291.Mdr 1020279-2017-00291 file will be updated and our investigation will continue against this event only.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 6
• 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: 6533703
• Report Number: 1020279-2017-00303
• Device Sequence Number: 768000
• Product Code: JWH
• UDI-Device Identifier: 00885556169964
• UDI-Public: 00885556169964
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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
• Report Date (Section B): 08/31/2017

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 Catalogue Number: 74022116
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 08/31/2017
• 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, 74022215 / UNK LOT; JRNY BCS PAT RESRF RD38MM STD, 74024838 / UNK LOT; JRNYIIBCS XLPE ART ISRT SZ5-6RT10MM,74027252/UNK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 106