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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 229
Loss of osseointegration 98
No code available 67
Dislodged or dislocated 34
Migration of device or device component 33
Implant, removal of 26
Corrosion 20
No Known Device Problem 20
Loose 19
Fracture 16
Loss of or failure to bond 15
Detachment of device component 12
Break 11
Malposition of device 8
Size incorrect for patient 7
Fitting problem 7
Mechanical issue 7
Metal shedding debris 5
Positioning Issue 5
Naturally worn 5
Material integrity issue 4
Slippage of device or device component 4
Loose or intermittent connection 4
Degraded 3
Dislocated 3
Material erosion 3
Device operates differently than expected 3
Unknown (for use when the device problem is not known) 3
Noise, Audible 3
Osseointegration issue 2
Manufacturing or shipping issue associated with device 2
Tear, rip or hole in device packaging 2
Unstable 2
Other (for use when an appropriate device code cannot be identified) 2
Component(s), worn 2
Explanted 2
Foreign material 1
Nonstandard device or device component 1
Difficult to remove 1
Component incompatible 1
Device expiration issue 1
Failure to osseointegrate 1
Use of Device Issue 1
Component missing 1
Device packaging compromised 1
Locking mechanism failure 1
Failure to Adhere or Bond 1
Mechanical jam 1
Foreign material present in device 1
Incompatibility problem 1
Item contaminated during manufacturing or shipping 1
Not Applicable 1
Total Device Problems 704

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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