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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 114
No Information 105
Fracture 86
Implant, removal of 64
Break 63
Unknown (for use when the device problem is not known) 41
Disassembly 36
Dislodged or dislocated 36
No code available 30
Loose or intermittent connection 23
Naturally worn 22
Explanted 22
Migration of device or device component 22
Detachment of device or device component 20
Component(s), broken 19
Mechanical issue 18
Loose 18
Tear, rip or hole in device packaging 18
Failure to Adhere or Bond 16
Unstable 16
Device operates differently than expected 15
Detachment of device component 14
Packaging issue 11
Component missing 10
Loss of or failure to bond 10
Material integrity issue 9
Difficult to insert 6
Fitting problem 6
Loss of osseointegration 5
Size incorrect for patient 5
Item contaminated during manufacturing or shipping 5
Unintended movement 5
Manufacturing or shipping issue associated with device 5
Source, incorrect 5
Patient-device incompatibility 5
Use of Device Issue 5
Degraded 4
Device markings issue 4
Device damaged prior to use 4
Out-of-box failure 4
Device packaging compromised 4
Device Issue 3
Component incompatible 3
Malfunction 3
Malposition of device 3
Component(s), worn 3
Noise, Audible 3
Other (for use when an appropriate device code cannot be identified) 3
Failure to expand 3
Delivered as unsterile product 3
Dislocated 3
Corrosion 3
Incompatibility problem 3
Defective component 3
Device inoperable 2
Device Cleaning Issue 2
Inaccurate delivery 2
Shelf life exceeded 2
Slippage of device or device component 2
Crack 2
Instruction for use issue 2
Material erosion 2
Positioning Issue 2
Material fragmentation 2
Failure to separate 2
Component or accessory incompatibility 2
Device remains implanted 2
Device-device incompatibility 2
Foreign material present in device 2
Incorrect device or component shipped 2
Biological environmental factor 1
Disengaged 1
Incomplete or missing packaging 1
Unsealed device packaging 1
Flaked 1
Disconnection 1
Entrapment of device or device component 1
Automatic injection system underinfusion 1
Insulation degradation 1
Difficult to position 1
Failure to align 1
Torn material 1
Bent 1
Pitted 1
Sterility 1
Failure to sterilize 1
Improper or incorrect procedure or method 1
Product quality issue 1
Device stops intermittently 1
Device contamination with blood or blood product 1
Replace 1
Residue after decontamination 1
Device displays error message 1
Locking mechanism failure 1
Disinfection or Sterilization Issue at User Location 1
Misassembled 1
Couple, failure to 1
Deployment issue 1
Shipping damage or problem 1
Not Applicable 1
Total Device Problems 1031

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 0
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 Stryker Howmedica Osteonics Corp. II Sep-29-2010
9 Stryker Howmedica Osteonics Corp. II Apr-17-2009
10 Zimmer Inc. II Mar-09-2009
11 Zimmer, Inc. II Mar-20-2014
12 Zimmer, Inc. II Jan-17-2014

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