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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 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
JOINT MEDICAL PRODUCTS CORP.
  1
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Information 751
Dislodged or dislocated 540
Fracture 99
Implant, removal of 90
Corrosion 89
No code available 84
Migration of device or device component 82
Failure to Adhere or Bond 71
Dislocated 62
Break 58
Disassembly 52
Naturally worn 52
Unstable 27
Malposition of device 25
Fitting problem 25
Difficult to insert 22
Mechanical issue 19
Unknown (for use when the device problem is not known) 14
Detachment of device component 13
Loss of osseointegration 12
Malfunction 10
No Known Device Problem 10
Material integrity issue 10
Slippage of device or device component 9
Incompatibility problem 8
Other (for use when an appropriate device code cannot be identified) 7
Component(s), worn 7
Material erosion 6
Material separation 6
Improper or incorrect procedure or method 5
Material deformation 5
Device operates differently than expected 5
Positioning Issue 5
Not Applicable 5
Loose or intermittent connection 5
Loose 5
Loss of or failure to bond 4
Use of Device Issue 4
Explanted 4
Tear, rip or hole in device packaging 4
Component missing 3
Noise, Audible 3
Device or device component damaged by another device 3
Detachment of device or device component 3
Crack 3
Metal shedding debris 3
Difficult to remove 3
Component incompatible 2
Osseointegration issue 2
Failure to separate 2
Biocompatibility issue 2
Failure to advance 1
Device Issue 1
Size incorrect for patient 1
Scratched material 1
Degraded 1
Compatibility 1
Component(s), broken 1
Bent 1
Foreign material 1
Disconnection 1
Disengaged 1
Material disintegration 1
Device abrasion from instrument or another object 1
Failure to osseointegrate 1
Misassembled 1
Delivered as unsterile product 1
Unsealed device packaging 1
User used incorrect product for intended use 1
Device remains implanted 1
Total Device Problems 2359

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