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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
  1.  K873627  CTI STRAIGHT STEM
  2.  K874617  THOMPSON HIP PROSTHESIS
STELKAST
  1
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  1

Device Problems
No Information 325
No code available 133
Implant, removal of 63
Dislodged or dislocated 53
Loss of osseointegration 41
Dislocated 25
Loose 24
Noise, Audible 21
Fracture 19
Corrosion 14
Metal shedding debris 11
Malposition of device 10
Unknown (for use when the device problem is not known) 8
Break 8
Other (for use when an appropriate device code cannot be identified) 7
Device remains implanted 5
Material integrity issue 5
Naturally worn 5
Disassembly 4
Loss of or failure to bond 4
Migration of device or device component 4
Patient-device incompatibility 3
No Known Device Problem 2
Nonstandard device or device component 2
Mechanical issue 2
Material erosion 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
Osseointegration issue 1
Incompatibility problem 1
Material deformation 1
Detachment of device or device component 1
Device misassembled during manufacturing or shipping 1
Difficult to remove 1
Total Device Problems 817

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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