MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930)
Date of Event	05/12/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was seen in the er and diagnosed with left leg cellulitis.He was ambulatory treated with oral antibiotics (500mg cephalexin 5 days 3x1 and bactrim 800/16mg 5 days 2x1) but was later on due to worsening of symptoms admitted for one night in hospital on (b)(6) 2017 where he was treated with iv antibiotic (clindamycin 300mg iv) after which was released for home with clindamycin 300mg p.O.3 days 4x1.On (b)(6) 2017 patient was once more hospitalised, treated i.V.Antibiotics (unspecified) to which the condition improved, until finally been resolved on 3rd day of hospitalisation when patient was released home with augmentin 875mg 7 days 2x1 and doxycycline hyclate 100mg 7 days 2x1.
Additional Manufacturer Narrative
Corrections based on additional information received.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our 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: JRNY BCS II FEMORAL OXIN LT SZ 8
• 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: 6847629
• Report Number: 1020279-2017-00716
• Device Sequence Number: 19232681
• Product Code: JWH
• UDI-Device Identifier: 00885556170564
• UDI-Public: 00885556170564
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 03/22/2022
• Device Catalogue Number: 74022128
• Device Lot Number: 12CM18836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/08/2017; 09/08/2017; 09/08/2017; 09/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/19/2017; 10/19/2017; 05/23/2018; 05/29/2018
• 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 LT SZ 6, 74022226/UNK LOT; JRNY BCS PAT BICONVEX 29 MM STD, 74024629/UNK LOT; JRNY II BCS XLPE ART ISRT SZ5-6LT9MM, 74027261/UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 125