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. JOURNEY TIBIA BASE NP RT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
  • 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. JOURNEY TIBIA BASE NP RT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Catalog Number 74022213
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code Pain (1994)
Date of Event 05/22/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain and mid flexion instability.
 
Additional Manufacturer Narrative
Additional information received by the customer has identified that this event has been already reported under 1020279-2019-02282.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JOURNEY TIBIA BASE NP RT SZ 3
Common Device Name
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8702655
Report Number1020279-2019-02286
Device Sequence Number2211499
Product Code JWH
UDI-Device Identifier03596010554277
UDI-Public03596010554277
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K042516
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/21/2019
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 Number74022213
Device Lot Number17FM21676
Initial Date Received by Manufacturer 05/22/2019
Supplement Date Received by Manufacturer06/19/2019
Initial Report FDA Received Date06/16/2019
Supplement Report FDA Received Date06/21/2019
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;
-
-