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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeMAY
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
PORTLAND ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fracture 25
No Information 24
Material integrity issue 17
Break 13
Mechanical issue 8
Detachment of device component 8
No Known Device Problem 7
Slippage of device or device component 6
Crack 4
Loose or intermittent connection 4
Fitting problem 4
Material deformation 4
Connection issue 4
Dislodged or dislocated 3
Device operates differently than expected 3
Mechanical jam 3
Manufacturing or shipping issue associated with device 3
Mechanics altered 3
Naturally worn 2
Noise, Audible 2
Difficult to remove 2
Unstable 2
Use of Device Issue 2
No code available 2
Metal shedding debris 1
Not Applicable 1
Device contamination with blood or blood product 1
Migration of device or device component 1
Implant, removal of 1
Split 1
Positioning Issue 1
Component falling 1
Disconnection 1
Failure to separate 1
Component or accessory incompatibility 1
Material Protrusion 1
Device-device incompatibility 1
Size incorrect for patient 1
Sticking 1
Total Device Problems 170

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 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. II Feb-25-2016

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