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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, femoral, resurfacing
Regulation Description Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
Product CodeKXA
Regulation Number 888.3400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BIOPRO, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 2098
No code available 686
Metal shedding debris 367
Noise, Audible 211
Loss of osseointegration 170
Dislodged or dislocated 125
Corrosion 73
Loss of or failure to bond 40
No Known Device Problem 33
Malposition of device 30
Implant, removal of 22
Fracture 21
Unknown (for use when the device problem is not known) 20
Naturally worn 15
Loose or intermittent connection 12
Break 12
Material erosion 7
Migration of device or device component 7
Loose 5
Device Issue 4
Other (for use when an appropriate device code cannot be identified) 3
Slippage of device or device component 3
Disassembly 3
Explanted 2
Component(s), broken 2
Mechanical issue 2
Difficult to remove 2
Patient-device incompatibility 2
Ambient noise issue 2
Connection issue 2
Material integrity issue 2
Osseointegration issue 1
Not Applicable 1
Device operates differently than expected 1
Malfunction 1
Defective item 1
Bent 1
Unstable 1
Failure to osseointegrate 1
Difficult to insert 1
Nonstandard device or device component 1
Delivered as unsterile product 1
Unsealed device packaging 1
User used incorrect product for intended use 1
Component(s), worn 1
Dislocated 1
Total Device Problems 3998

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

Recalls
Manufacturer Recall Class Date Posted
1 Depuy Orthopaedics, Inc. II Mar-24-2011
2 Zimmer Inc. II Nov-29-2007
3 Zimmer, Inc. II Nov-06-2012

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