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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.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAYES
  SUBSTANTIALLY EQUIVALENT 3
IMPLEX
  SUBSTANTIALLY EQUIVALENT 2
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 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
Unknown (for use when the device problem is not known) 171
Break 170
No Known Device Problem 110
Component(s), broken 67
No Information 53
Implant, removal of 30
Loose 29
Explanted 22
Loss of osseointegration 19
Fracture 14
Dislodged or dislocated 13
Loose or intermittent connection 10
Migration of device or device component 8
Corrosion 8
No code available 8
Loss of or failure to bond 6
Fitting problem 4
Other (for use when an appropriate device code cannot be identified) 4
Naturally worn 4
Difficult to remove 3
Disassembly 3
Dislocated 2
Detachment of device component 2
Malposition of device 2
Component or accessory incompatibility 1
Defective item 1
Material perforation 1
Component missing 1
Size incorrect for patient 1
Use of Device Issue 1
Noise 1
Component(s), worn 1
Component incompatible 1
Material erosion 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Foreign material 1
Compatibility 1
Total Device Problems 776

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 4 0 0 0 0
Class III 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

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