• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device prosthesis, hip, hemi-, femoral, metal
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeKWL
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 6
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
  5
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAYES
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Information 80
Loss of osseointegration 47
Implant, removal of 26
Loose 19
No code available 19
Migration of device or device component 18
Dislodged or dislocated 14
Loss of or failure to bond 13
Fracture 12
No Known Device Problem 10
Corrosion 8
Break 5
Fitting problem 5
Size incorrect for patient 4
Slippage of device or device component 3
Loose or intermittent connection 3
Dislocated 3
Mechanical issue 3
Unknown (for use when the device problem is not known) 3
Malposition of device 3
Device operates differently than expected 3
Naturally worn 3
Positioning Issue 3
Material integrity issue 2
Tear, rip or hole in device packaging 2
Other (for use when an appropriate device code cannot be identified) 2
Detachment of device component 2
Component(s), worn 2
Explanted 2
Foreign material 1
Use of Device Issue 1
Metal shedding debris 1
Component incompatible 1
Device expiration issue 1
Degraded 1
Component missing 1
Device packaging compromised 1
Locking mechanism failure 1
Foreign material present in device 1
Item contaminated during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Mechanical jam 1
Osseointegration issue 1
Total Device Problems 333

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 1 0 0 0 0 0 0 1
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Jan-05-2016
2 Stryker Howmedica Osteonics Corp. III Sep-14-2009
3 Stryker Howmedica Osteonics Corp. II Jul-22-2009
4 Stryker Howmedica Osteonics Corp. II Mar-20-2008
5 Stryker Howmedica Osteonics Corp. II Jan-13-2007

-
-