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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Description Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Product CodeKWZ
Regulation Number 888.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
JOINT MEDICAL PRODUCTS CORP.
  1
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Dislodged or dislocated 255
No Information 231
Implant, removal of 90
Dislocated 62
Fracture 59
Corrosion 43
No code available 42
Break 40
Disassembly 36
Failure to Adhere or Bond 31
Fitting problem 25
Naturally worn 19
Migration of device or device component 15
Difficult to insert 14
Unknown (for use when the device problem is not known) 14
Malposition of device 12
Unstable 11
Malfunction 10
Mechanical issue 9
Slippage of device or device component 7
Component(s), worn 7
Other (for use when an appropriate device code cannot be identified) 7
Detachment of device component 6
Material separation 6
Loose or intermittent connection 5
Loose 5
Loss of osseointegration 5
Device operates differently than expected 5
Material integrity issue 5
Not Applicable 5
Improper or incorrect procedure or method 4
Tear, rip or hole in device packaging 4
Explanted 4
Material erosion 3
Component missing 3
Material deformation 3
No Known Device Problem 3
Positioning Issue 3
Detachment of device or device component 2
Loss of or failure to bond 2
Component incompatible 2
Difficult to remove 2
Use of Device Issue 2
Metal shedding debris 1
Failure to osseointegrate 1
Delivered as unsterile product 1
Unsealed device packaging 1
User used incorrect product for intended use 1
Device remains implanted 1
Bent 1
Compatibility 1
Component(s), broken 1
Foreign material 1
Disconnection 1
Disengaged 1
Failure to advance 1
Device Issue 1
Noise, Audible 1
Total Device Problems 1133

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 0 0 0 1 0 2 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Sep-20-2012
2 Smith & Nephew Inc II Oct-18-2010
3 Smith & Nephew, Inc. II Jun-09-2015
4 Zimmer, Inc. II Nov-20-2012

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