Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER Back to Search Results
Model Number 74027261
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/17/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to an infection 9 days post-operation.Surgeon performed an incision and drainage.Poly was changed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM
Common Device Name
PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9659095
Report Number1020279-2020-00450
Device Sequence Number18932793
Product Code JWH
UDI-Device Identifier00885556177969
UDI-Public00885556177969
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source consumer,health professional
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/10/2020
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 Model Number74027261
Device Catalogue Number74027261
Device Lot Number18FM05914
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/17/2020
Supplement Date Received by Manufacturer12/08/2020
Initial Report FDA Received Date02/03/2020
Supplement Report FDA Received Date12/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
-
-