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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 cemented acetabular component)
Regulation Description Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
Product CodeJDL
Regulation Number 888.3320
Device Class 3


Premarket Reviews
ManufacturerDecision
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  1
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 7
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 541
No Known Device Problem 191
Implant, removal of 184
Naturally worn 165
Component(s), worn 120
Dislodged or dislocated 81
Unknown (for use when the device problem is not known) 65
Loose or intermittent connection 34
Dislocated 32
Loss of osseointegration 29
Corrosion 23
Loose 21
Malposition of device 21
Fracture 20
Break 19
Metal shedding debris 17
Migration of device or device component 15
Other (for use when an appropriate device code cannot be identified) 12
Noise, Audible 11
Disassembly 9
No code available 8
Device operates differently than expected 6
Device remains implanted 6
Material erosion 6
Loss of or failure to bond 6
Component(s), broken 5
Slippage of device or device component 5
Unstable 5
Size incorrect for patient 3
Difficult to remove 3
Detachment of device component 3
Component incompatible 3
Degraded 3
Ambient noise issue 3
Positioning Issue 3
Packaging issue 2
Component or accessory incompatibility 2
Material integrity issue 2
Displacement 2
Material separation 2
User used incorrect product for intended use 2
Use of Device Issue 2
Sticking 1
Fitting problem 1
Difficult to position 1
Explanted 1
Material frayed 1
Crack 1
Compatibility 1
Incompatibility problem 1
Device-device incompatibility 1
Incomplete or missing packaging 1
Delamination 1
Device markings issue 1
Patient-device incompatibility 1
Misassembled by Users 1
Not Applicable 1
Total Device Problems 1707

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

Recalls
Manufacturer Recall Class Date Posted
1 Wright Medical Technology Inc II Jun-25-2015
2 Wright Medical Technology Inc III Aug-12-2010

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