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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 248
Unknown (for use when the device problem is not known) 171
No Information 142
No Known Device Problem 124
Component(s), broken 67
Fracture 57
Loss of osseointegration 41
Dislodged or dislocated 37
Corrosion 36
No code available 33
Implant, removal of 30
Loose 29
Naturally worn 24
Explanted 22
Migration of device or device component 20
Loose or intermittent connection 17
Metal shedding debris 9
Loss of or failure to bond 7
Device operates differently than expected 7
Detachment of device component 6
Failure to Adhere or Bond 6
Slippage of device or device component 6
Unstable 6
Fitting problem 5
Other (for use when an appropriate device code cannot be identified) 4
Difficult to remove 4
Noise, Audible 4
Component missing 3
Material integrity issue 3
Malposition of device 3
Size incorrect for patient 3
Disassembly 3
Degraded 2
Dislocated 2
Component incompatible 2
Use of Device Issue 2
Positioning Issue 2
Not Applicable 1
Component or accessory incompatibility 1
Defective item 1
Device Issue 1
Material perforation 1
Osseointegration issue 1
Packaging issue 1
Foreign material present in device 1
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
Biofilm coating in device 1
Collapse 1
Compatibility 1
Material erosion 1
Device expiration issue 1
Foreign material 1
Material discolored 1
Total Device Problems 1212

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 4 0 0 0 0 1 0 1 0
Class III 0 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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