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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 466
No code available 161
Dislodged or dislocated 84
Implant, removal of 63
Loss of osseointegration 60
Noise, Audible 26
Dislocated 25
Loose 24
Fracture 22
Corrosion 19
Migration of device or device component 16
Malposition of device 14
Metal shedding debris 14
Break 13
Naturally worn 12
Unknown (for use when the device problem is not known) 8
Loss of or failure to bond 8
Other (for use when an appropriate device code cannot be identified) 7
Unstable 7
Material erosion 6
Device remains implanted 5
Material integrity issue 4
No Known Device Problem 4
Patient-device incompatibility 3
Detachment of device or device component 3
Mechanical issue 3
Disassembly 3
Component(s), worn 2
Component(s), broken 2
Nonstandard device or device component 2
Device misassembled during manufacturing or shipping 2
Positioning Issue 2
Incompatibility problem 2
Material deformation 2
Unintended movement 1
Device expiration issue 1
Loose or intermittent connection 1
Detachment of device component 1
Failure to Adhere or Bond 1
Crack 1
Degraded 1
Total Device Problems 1101

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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