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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 289
No Information 282
Implant, removal of 90
Fracture 64
Dislocated 62
Corrosion 54
Failure to Adhere or Bond 44
No code available 44
Break 43
Disassembly 38
Fitting problem 25
Naturally worn 21
Difficult to insert 17
Migration of device or device component 17
Malposition of device 16
Unstable 15
Unknown (for use when the device problem is not known) 14
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
Loss of osseointegration 6
Material integrity issue 6
Detachment of device component 6
Material separation 6
Loose or intermittent connection 5
Loose 5
Not Applicable 5
Device operates differently than expected 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
Compatibility 1
Component(s), broken 1
Bent 1
Foreign material 1
Disconnection 1
Disengaged 1
Failure to advance 1
Device Issue 1
Noise, Audible 1
Total Device Problems 1271

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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