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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 128
No Information 119
Fracture 97
Break 74
Implant, removal of 64
Unknown (for use when the device problem is not known) 41
Dislodged or dislocated 41
Disassembly 40
No code available 30
Naturally worn 26
Migration of device or device component 26
Loose or intermittent connection 23
Explanted 22
Detachment of device or device component 20
Component(s), broken 19
Loose 18
Mechanical issue 18
Tear, rip or hole in device packaging 18
Unstable 17
Failure to Adhere or Bond 16
Device operates differently than expected 15
Detachment of device component 14
Loss of or failure to bond 11
Packaging issue 11
Material integrity issue 10
Component missing 10
Manufacturing or shipping issue associated with device 8
Device packaging compromised 6
Unintended movement 6
Fitting problem 6
Loss of osseointegration 6
Patient-device incompatibility 6
Difficult to insert 6
Degraded 5
Use of Device Issue 5
Device damaged prior to use 5
Size incorrect for patient 5
Source, incorrect 5
Item contaminated during manufacturing or shipping 5
Device markings issue 4
Improper or incorrect procedure or method 4
Out-of-box failure 4
Malfunction 3
Device Issue 3
Malposition of device 3
Other (for use when an appropriate device code cannot be identified) 3
Defective component 3
Shipping damage or problem 3
Dislocated 3
Component(s), worn 3
Component incompatible 3
Corrosion 3
Delivered as unsterile product 3
Incompatibility problem 3
Incorrect device or component shipped 3
Failure to expand 3
Noise, Audible 3
Positioning Issue 2
Component or accessory incompatibility 2
Device-device incompatibility 2
Foreign material present in device 2
Device remains implanted 2
Instruction for use issue 2
Material fragmentation 2
Device Cleaning Issue 2
Material erosion 2
Crack 2
Shelf life exceeded 2
Slippage of device or device component 2
Device inoperable 2
Inaccurate delivery 2
Failure to separate 2
Device displays error message 1
Locking mechanism failure 1
Biological environmental factor 1
Disinfection or Sterilization Issue at User Location 1
Failure to align 1
Incomplete or missing packaging 1
Device contamination with blood or blood product 1
Residue after decontamination 1
Sterility 1
Failure to sterilize 1
Device stops intermittently 1
Automatic injection system underinfusion 1
Disconnection 1
Disengaged 1
Entrapment of device or device component 1
Bent 1
Couple, failure to 1
Flaked 1
Insulation degradation 1
Replace 1
Misassembled 1
Unsealed device packaging 1
Pitted 1
Difficult to position 1
Product quality issue 1
Deployment issue 1
Torn material 1
Not Applicable 1
Total Device Problems 1117

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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