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 DCF AP FEM CUT BLK 9; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
  • 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 DCF AP FEM CUT BLK 9; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 74012419
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/08/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event or Problem Description
It was reported that, during a tka, a part of a journey dcf ap fem cut blk 9 broke off.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JOURNEY DCF AP FEM CUT BLK 9
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12539800
Report Number1020279-2021-07243
Device Sequence Number1442763
Product Code HRY
UDI-Device Identifier03596010556714
UDI-Public03596010556714
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K121393
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/06/2021
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 No Information
Device Model Number74012419
Device Catalogue Number74012419
Device Lot Number19CM22783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
Initial Date Received by Manufacturer 09/08/2021
Supplement Date Received by Manufacturer10/05/2021
Initial Report FDA Received Date09/28/2021
Supplement Report FDA Received Date10/06/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-