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 CR FEM OX NP LT SZ 5; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONS, CEM, 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. JRNY II CR FEM OX NP LT SZ 5; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONS, CEM, POLY/METAL/POLY Back to Search Results
Model Number 74021165
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 09/11/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the clinical subject had been experiencing problems associated with stiffness on his surgery knee.The subject attempted physical therapy but ended up developing arthrofibrosis.The event was treated via manipulation under anesthesia and its outcome is considered unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JRNY II CR FEM OX NP LT SZ 5
Common Device Name
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONS, CEM, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9978070
Report Number1020279-2020-01325
Device Sequence Number19657311
Product Code JWH
UDI-Device Identifier00885556422786
UDI-Public00885556422786
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121443
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional,study,use
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/16/2021
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 Number74021165
Device Catalogue Number74021165
Device Lot Number17EM07575
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/30/2020
Supplement Date Received by Manufacturer08/12/2021
Initial Report FDA Received Date04/20/2020
Supplement Report FDA Received Date08/16/2021
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;
Patient Age62 YR
Patient Weight80
-
-