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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 163
Loss of osseointegration 87
No code available 59
Migration of device or device component 29
Implant, removal of 26
Dislodged or dislocated 20
Loose 19
No Known Device Problem 16
Loss of or failure to bond 15
Corrosion 15
Fracture 14
Break 11
Detachment of device component 8
Size incorrect for patient 7
Fitting problem 6
Malposition of device 6
Mechanical issue 6
Positioning Issue 5
Metal shedding debris 4
Material integrity issue 4
Naturally worn 4
Loose or intermittent connection 4
Slippage of device or device component 4
Unknown (for use when the device problem is not known) 3
Device operates differently than expected 3
Degraded 3
Dislocated 3
Material erosion 3
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
Unstable 2
Noise, Audible 2
Manufacturing or shipping issue associated with device 2
Osseointegration issue 2
Not Applicable 1
Mechanical jam 1
Use of Device Issue 1
Component missing 1
Locking mechanism failure 1
Device packaging compromised 1
Foreign material present in device 1
Item contaminated during manufacturing or shipping 1
Foreign material 1
Nonstandard device or device component 1
Difficult to remove 1
Component incompatible 1
Device expiration issue 1
Total Device Problems 576

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 1 1 0 0 0 0 0 0 1 0
Class III 0 0 1 0 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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