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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 225
Unknown (for use when the device problem is not known) 171
No Known Device Problem 123
No Information 117
Component(s), broken 67
Fracture 55
Loss of osseointegration 37
Dislodged or dislocated 34
Corrosion 31
Implant, removal of 30
No code available 30
Loose 29
Explanted 22
Naturally worn 22
Migration of device or device component 17
Loose or intermittent connection 16
Metal shedding debris 9
Device operates differently than expected 7
Unstable 6
Detachment of device component 6
Loss of or failure to bond 6
Failure to Adhere or Bond 5
Fitting problem 5
Slippage of device or device component 5
Other (for use when an appropriate device code cannot be identified) 4
Difficult to remove 4
Size incorrect for patient 3
Disassembly 3
Component missing 3
Malposition of device 3
Material integrity issue 2
Positioning Issue 2
Noise, Audible 2
Degraded 2
Dislocated 2
Component incompatible 2
Use of Device Issue 2
Improper or incorrect procedure or method 1
Noise 1
Material rigid or stiff 1
Material separation 1
Material fragmentation 1
Unsealed device packaging 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Component(s), worn 1
Battery charger, defective 1
Collapse 1
Compatibility 1
Material erosion 1
Device expiration issue 1
Foreign material 1
Material discolored 1
Osseointegration issue 1
Packaging issue 1
Component or accessory incompatibility 1
Foreign material present in device 1
Material perforation 1
Device Issue 1
Defective item 1
Total Device Problems 1132

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 1
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 MicroPort Orthopedics Inc. II Aug-18-2016
3 Stelkast Co II Mar-31-2009
4 Stelkast Co II Jan-28-2009
5 Stryker Howmedica Osteonics Corp. II Aug-18-2009
6 Zimmer Inc. II Jul-06-2009
7 Zimmer, Inc. II Feb-20-2014

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