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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 282
No Information 220
Unknown (for use when the device problem is not known) 171
No Known Device Problem 124
Dislodged or dislocated 68
Component(s), broken 67
Fracture 61
Loss of osseointegration 48
Corrosion 36
Dull 35
No code available 35
Implant, removal of 30
Loose 29
Migration of device or device component 24
Naturally worn 24
Explanted 22
Loose or intermittent connection 18
Metal shedding debris 12
Unstable 8
Loss of or failure to bond 8
Device operates differently than expected 7
Slippage of device or device component 6
Fitting problem 6
Detachment of device component 6
Failure to Adhere or Bond 6
Disassembly 5
Difficult to remove 4
Other (for use when an appropriate device code cannot be identified) 4
Malposition of device 4
Noise, Audible 4
Material integrity issue 3
Component missing 3
Size incorrect for patient 3
Use of Device Issue 2
Degraded 2
Dislocated 2
Component incompatible 2
Incompatibility problem 2
Positioning Issue 2
Not Applicable 1
Osseointegration issue 1
Packaging issue 1
Device Issue 1
Material perforation 1
Component or accessory incompatibility 1
Defective item 1
Device or device component damaged by another device 1
Foreign material present in device 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
Noise 1
Material rigid or stiff 1
Material separation 1
Unsealed device packaging 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Mechanical issue 1
Material fragmentation 1
Total Device Problems 1421

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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