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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 1804
No code available 404
Metal shedding debris 326
Noise, Audible 169
Loss of osseointegration 141
Dislodged or dislocated 93
Loss of or failure to bond 38
Corrosion 38
No Known Device Problem 31
Malposition of device 27
Implant, removal of 22
Unknown (for use when the device problem is not known) 20
Fracture 18
Naturally worn 15
Loose or intermittent connection 12
Break 9
Material erosion 5
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
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 3216

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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