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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 396
No code available 171
Implant, removal of 63
Dislodged or dislocated 61
Loss of osseointegration 53
Dislocated 25
Noise, Audible 25
Loose 24
Fracture 22
Corrosion 15
Metal shedding debris 13
Malposition of device 12
Break 11
Migration of device or device component 8
Unknown (for use when the device problem is not known) 8
Other (for use when an appropriate device code cannot be identified) 7
Loss of or failure to bond 7
Material integrity issue 6
Naturally worn 6
Device remains implanted 5
Disassembly 4
No Known Device Problem 3
Patient-device incompatibility 3
Mechanical issue 3
Material erosion 3
Nonstandard device or device component 2
Component(s), broken 2
Component(s), worn 2
Degraded 2
Crack 1
Detachment of device component 1
Failure to Adhere or Bond 1
Device expiration issue 1
Loose or intermittent connection 1
Detachment of device or device component 1
Device misassembled during manufacturing or shipping 1
Difficult to remove 1
Osseointegration issue 1
Positioning Issue 1
Incompatibility problem 1
Material deformation 1
Total Device Problems 974

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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