MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022117
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/14/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following total knee replacement surgery patient had a knee infection and effusion.Patient was hospitalised and administered with iv antibiotics.
Additional Manufacturer Narrative
Corrections based on additional information received.
Event or Problem Description
Patient was administered with 1g rocephin i.V.
Additional Manufacturer Narrative
Data previously reported under is to be corrected to: jrnyiibcs xlpe isrt sz7-8rt11mm;74027273/13bm05507, journey tibia base np rt sz 7; 74022217 /13am13714, jrny bcs pat resrf rd41mm std;74024841/13cm01955.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 7
• 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: 6837893
• Report Number: 1020279-2017-00690
• Device Sequence Number: 13657742
• Product Code: JWH
• UDI-Device Identifier: 00885556170014
• UDI-Public: 00885556170014
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/26/2017

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: 03/09/2023
• Device Catalogue Number: 74022117
• Device Lot Number: 13CM06816
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 09/01/2017; 09/01/2017; 09/01/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/11/2017; 10/16/2017; 10/26/2017
• 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 7, 74022217 / UNK LOT; JRNY BCS PAT RESRF RD 38 MM STD, 74024838/UNK LOT; JRNYIIBCS XLPE ISRT SZ7-8RT11MM, 74027273/UNK LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 108