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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 1745
No code available 340
Metal shedding debris 317
Noise, Audible 161
Loss of osseointegration 128
Dislodged or dislocated 90
Corrosion 38
Loss of or failure to bond 37
No Known Device Problem 31
Malposition of device 25
Implant, removal of 22
Unknown (for use when the device problem is not known) 20
Fracture 18
Naturally worn 14
Loose or intermittent connection 12
Break 8
Loose 5
Device Issue 4
Other (for use when an appropriate device code cannot be identified) 3
Slippage of device or device component 3
Migration of device or device component 3
Disassembly 3
Material erosion 3
Explanted 2
Component(s), broken 2
Patient-device incompatibility 2
Ambient noise issue 2
Connection issue 2
Material integrity issue 1
Malfunction 1
Defective item 1
Unstable 1
Failure to osseointegrate 1
Bent 1
Component(s), worn 1
Dislocated 1
Nonstandard device or device component 1
Unsealed device packaging 1
User used incorrect product for intended use 1
Mechanical issue 1
Not Applicable 1
Total Device Problems 3053

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 0 0 0 1 1 0 0 0 0
Class III 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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