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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Product CodeKRO
Regulation Number 888.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  1
  SUBSTANTIALLY EQUIVALENT 13
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DOW
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 9
SULZER
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Known Device Problem 151
No Information 147
Fracture 115
Break 85
Implant, removal of 64
Dislodged or dislocated 47
Disassembly 46
Unknown (for use when the device problem is not known) 41
No code available 33
Naturally worn 30
Migration of device or device component 29
Loose or intermittent connection 23
Explanted 22
Tear, rip or hole in device packaging 21
Mechanical issue 20
Detachment of device or device component 20
Component(s), broken 19
Failure to Adhere or Bond 18
Loose 18
Unstable 18
Device operates differently than expected 18
Detachment of device component 14
Material integrity issue 13
Packaging issue 12
Loss of or failure to bond 11
Component missing 10
Manufacturing or shipping issue associated with device 10
Unintended movement 8
Incorrect device or component shipped 7
Device damaged prior to use 7
Fitting problem 6
Loss of osseointegration 6
Difficult to insert 6
Device packaging compromised 6
Patient-device incompatibility 6
Item contaminated during manufacturing or shipping 5
Degraded 5
Out-of-box failure 5
Use of Device Issue 5
Size incorrect for patient 5
Source, incorrect 5
Improper or incorrect procedure or method 4
Defective component 4
Device Issue 4
Material erosion 4
Delivered as unsterile product 4
Device markings issue 4
Incompatibility problem 3
Failure to expand 3
Noise, Audible 3
Dislocated 3
Component(s), worn 3
Component incompatible 3
Corrosion 3
Malposition of device 3
Malfunction 3
Other (for use when an appropriate device code cannot be identified) 3
Shipping damage or problem 3
Shelf life exceeded 2
Device remains implanted 2
Slippage of device or device component 2
Failure to separate 2
Incomplete or missing packaging 2
Device inoperable 2
Inaccurate delivery 2
Device Cleaning Issue 2
Crack 2
Instruction for use issue 2
Material fragmentation 2
Positioning Issue 2
Foreign material present in device 2
Device-device incompatibility 2
Component or accessory incompatibility 2
Deployment issue 1
Biological environmental factor 1
Disinfection or Sterilization Issue at User Location 1
Mechanical jam 1
Torn material 1
Not Applicable 1
Flaked 1
Insulation degradation 1
Unsealed device packaging 1
Pitted 1
Difficult to position 1
Product quality issue 1
Misassembled 1
Failure to deploy 1
Entrapment of device or device component 1
Disconnection 1
Disengaged 1
Bent 1
Couple, failure to 1
Residue after decontamination 1
Device contamination with blood or blood product 1
Automatic injection system underinfusion 1
Device displays error message 1
Locking mechanism failure 1
Failure to align 1
Difficult to remove 1
Replace 1
Total Device Problems 1251

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 2 3 1 0 2 0 3 1 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-19-2012
2 Biomet, Inc. II Jan-11-2012
3 Biomet, Inc. II Jun-29-2009
4 Biomet, Inc. II Sep-17-2008
5 Biomet, Inc. II Sep-11-2008
6 DePuy Orthopaedics, Inc. II Mar-13-2014
7 Medacta Usa II Nov-14-2015
8 Smith & Nephew, Inc. II Jun-29-2016
9 Stanmore Implants Worldwide Ltd. II Aug-17-2016
10 Stryker Howmedica Osteonics Corp. II Sep-29-2010
11 Stryker Howmedica Osteonics Corp. II Apr-17-2009
12 Zimmer Inc. II Mar-09-2009
13 Zimmer, Inc. II Mar-20-2014
14 Zimmer, Inc. II Jan-17-2014

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