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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 95
Loss of osseointegration 66
Implant, removal of 26
No code available 25
Migration of device or device component 22
Loose 19
Dislodged or dislocated 15
Loss of or failure to bond 15
Fracture 13
No Known Device Problem 12
Corrosion 10
Break 7
Size incorrect for patient 5
Fitting problem 5
Mechanical issue 4
Material integrity issue 4
Malposition of device 3
Device operates differently than expected 3
Unknown (for use when the device problem is not known) 3
Slippage of device or device component 3
Loose or intermittent connection 3
Degraded 3
Dislocated 3
Naturally worn 3
Positioning Issue 3
Manufacturing or shipping issue associated with device 2
Osseointegration issue 2
Detachment of device component 2
Component(s), worn 2
Explanted 2
Tear, rip or hole in device packaging 2
Other (for use when an appropriate device code cannot be identified) 2
Component missing 1
Device packaging compromised 1
Locking mechanism failure 1
Mechanical jam 1
Foreign material present in device 1
Item contaminated during manufacturing or shipping 1
Foreign material 1
Use of Device Issue 1
Metal shedding debris 1
Component incompatible 1
Device expiration issue 1
Total Device Problems 395

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

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