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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeLWJ
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  2
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAYES
  SUBSTANTIALLY EQUIVALENT 3
IMPLEX
  SUBSTANTIALLY EQUIVALENT 2
JOINT MEDICAL PRODUCTS CORP.
  2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 7
STELKAST
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SULZER
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 204
Unknown (for use when the device problem is not known) 171
No Known Device Problem 123
No Information 100
Component(s), broken 67
Fracture 51
Loss of osseointegration 33
Implant, removal of 30
Loose 29
Corrosion 29
No code available 28
Dislodged or dislocated 24
Naturally worn 22
Explanted 22
Migration of device or device component 16
Loose or intermittent connection 15
Metal shedding debris 9
Loss of or failure to bond 6
Detachment of device component 6
Device operates differently than expected 6
Fitting problem 5
Slippage of device or device component 5
Unstable 5
Difficult to remove 4
Other (for use when an appropriate device code cannot be identified) 4
Failure to Adhere or Bond 3
Disassembly 3
Malposition of device 3
Size incorrect for patient 3
Component missing 3
Noise, Audible 2
Positioning Issue 2
Dislocated 2
Use of Device Issue 2
Material rigid or stiff 1
Material separation 1
Improper or incorrect procedure or method 1
Noise 1
Material fragmentation 1
Unsealed device packaging 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Material erosion 1
Device expiration issue 1
Foreign material 1
Material discolored 1
Degraded 1
Battery charger, defective 1
Collapse 1
Compatibility 1
Component(s), worn 1
Component incompatible 1
Material perforation 1
Device Issue 1
Defective item 1
Component or accessory incompatibility 1
Foreign material present in device 1
Material integrity issue 1
Osseointegration issue 1
Total Device Problems 1062

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 1 0 4 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems II Dec-11-2007
2 Stelkast Co II Mar-31-2009
3 Stelkast Co II Jan-28-2009
4 Stryker Howmedica Osteonics Corp. II Aug-18-2009
5 Zimmer Inc. II Jul-06-2009
6 Zimmer, Inc. II Feb-20-2014

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