MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIB BPLT LT SZ 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71933634
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	07/31/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient required remedial therapy in order to solve post-opertative cellulitis of the left knee.Outcome of this event is deemed as resolved, severity as moderate and the therapy comprised of keflex 500mg 2x1.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.(b)(4).
Additional Manufacturer Narrative
Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Additional Manufacturer Narrative
Please take in consideration the file attached for the previous report submitted.

• Brand Name: JOURNEY TIB BPLT LT SZ 9
• 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: 6833819
• Report Number: 1020279-2017-00681
• Device Sequence Number: 19232618
• Product Code: JWH
• UDI-Device Identifier: 00885556063477
• UDI-Public: 00885556063477
• 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,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2018

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: 10/08/2018
• Device Catalogue Number: 71933634
• Device Lot Number: 08KM07941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/04/2017; 08/04/2017; 08/04/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/10/2017; 05/23/2018; 05/29/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURN ART INS BCS STD 7-8 LT10,(B)(4); JOURNEY FEM OX NP BCS LT SZ 9,(B)(4); JRNY BCS PAT RESRF RD 41 MM STD,(B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 123