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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 196
No Known Device Problem 190
Implant, removal of 184
Naturally worn 161
Component(s), worn 120
Unknown (for use when the device problem is not known) 65
Dislodged or dislocated 59
Dislocated 32
Loss of osseointegration 29
Loose or intermittent connection 24
Loose 21
Malposition of device 17
Fracture 15
Corrosion 12
Other (for use when an appropriate device code cannot be identified) 12
Metal shedding debris 11
Noise, Audible 9
Break 8
Migration of device or device component 8
Disassembly 7
Device remains implanted 6
Loss of or failure to bond 6
Device operates differently than expected 6
Component(s), broken 5
Slippage of device or device component 5
Size incorrect for patient 3
Unstable 3
Detachment of device component 3
Degraded 3
Ambient noise issue 3
Positioning Issue 3
No code available 3
Material integrity issue 2
Component or accessory incompatibility 2
Displacement 2
Component incompatible 2
Use of Device Issue 2
Difficult to remove 2
Material separation 2
User used incorrect product for intended use 2
Material frayed 1
Sticking 1
Patient-device incompatibility 1
Crack 1
Compatibility 1
Explanted 1
Difficult to position 1
Delamination 1
Device markings issue 1
Device-device incompatibility 1
Incomplete or missing packaging 1
Misassembled by Users 1
Not Applicable 1
Packaging issue 1
Total Device Problems 1259

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 1 0
Class III 0 0 0 1 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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