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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 455
No code available 225
Dislodged or dislocated 72
Implant, removal of 63
Loss of osseointegration 61
Noise, Audible 31
Dislocated 25
Loose 24
Fracture 23
Corrosion 22
Metal shedding debris 20
Malposition of device 14
Break 11
Loss of or failure to bond 9
Migration of device or device component 8
Unknown (for use when the device problem is not known) 8
Naturally worn 7
Other (for use when an appropriate device code cannot be identified) 7
Mechanical issue 7
Material integrity issue 6
Device remains implanted 5
No Known Device Problem 4
Disassembly 4
Patient-device incompatibility 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
Incompatibility problem 1
Detachment of device or device component 1
Device misassembled during manufacturing or shipping 1
Difficult to remove 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 1140

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 1 0 0 0 1 3 0 0
Class III 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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