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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 component, cemented, metal
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeJDG
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  2
  SUBSTANTIALLY EQUIVALENT 3
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 4
DOW
  SUBSTANTIALLY EQUIVALENT 1
  2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOINT MEDICAL PRODUCTS CORP.
  1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
STELKAST
  1
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  1

Device Problems
No Information 483
No code available 243
Dislodged or dislocated 78
Loss of osseointegration 64
Implant, removal of 63
Noise, Audible 36
Dislocated 25
Fracture 24
Loose 24
Corrosion 22
Metal shedding debris 22
Malposition of device 14
Break 11
Migration of device or device component 10
Mechanical issue 9
Loss of or failure to bond 9
Naturally worn 9
Unknown (for use when the device problem is not known) 8
Other (for use when an appropriate device code cannot be identified) 7
Material integrity issue 6
Device remains implanted 5
Disassembly 4
No Known Device Problem 4
Patient-device incompatibility 3
Detachment of device or device component 3
Material erosion 3
Nonstandard device or device component 2
Component(s), broken 2
Component(s), worn 2
Degraded 2
Osseointegration issue 2
Positioning Issue 2
Material deformation 2
Unintended movement 1
Incompatibility problem 1
Device misassembled during manufacturing or shipping 1
Difficult to remove 1
Unstable 1
Crack 1
Detachment of device component 1
Failure to Adhere or Bond 1
Device expiration issue 1
Loose or intermittent connection 1
Total Device Problems 1213

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 1 0 0 0 1 3 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. II Nov-23-2009
2 Zimmer, Inc. II Aug-26-2014
3 Zimmer, Inc. II Aug-13-2014
4 Zimmer, Inc. II Feb-20-2014
5 Zimmer, Inc. II Aug-17-2013

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