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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 202
No Information 177
Fracture 130
Break 91
Implant, removal of 64
Dislodged or dislocated 52
Disassembly 46
Unknown (for use when the device problem is not known) 41
Migration of device or device component 35
Naturally worn 34
No code available 33
Loose or intermittent connection 30
Explanted 22
Tear, rip or hole in device packaging 21
Unstable 20
Mechanical issue 20
Failure to Adhere or Bond 20
Detachment of device or device component 20
Device operates differently than expected 20
Component(s), broken 19
Loose 18
Packaging issue 17
Detachment of device component 16
Component missing 14
Material integrity issue 14
Loss of or failure to bond 11
Incorrect device or component shipped 10
Manufacturing or shipping issue associated with device 10
Unintended movement 10
Device damaged prior to use 8
Loss of osseointegration 8
Device packaging compromised 7
Patient-device incompatibility 6
Fitting problem 6
Difficult to insert 6
Material erosion 5
Degraded 5
Improper or incorrect procedure or method 5
Use of Device Issue 5
Size incorrect for patient 5
Source, incorrect 5
Device Issue 5
Out-of-box failure 5
Device markings issue 5
Item contaminated during manufacturing or shipping 5
Component or accessory incompatibility 4
Defective component 4
Delivered as unsterile product 4
Instruction for use issue 3
Dislocated 3
Component(s), worn 3
Component incompatible 3
Corrosion 3
Malfunction 3
Shipping damage or problem 3
Other (for use when an appropriate device code cannot be identified) 3
Device-device incompatibility 3
Malposition of device 3
Incompatibility problem 3
Failure to expand 3
Noise, Audible 3
Positioning Issue 2
Foreign material present in device 2
Device inoperable 2
Slippage of device or device component 2
Shelf life exceeded 2
Device remains implanted 2
Inaccurate delivery 2
Failure to separate 2
Incomplete or missing packaging 2
Device Cleaning Issue 2
Crack 2
Material fragmentation 2
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
Device contamination with blood or blood product 1
Residue after decontamination 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
Sterility 1
Failure to sterilize 1
Device stops intermittently 1
Metal shedding debris 1
Mechanical jam 1
Device misassembled during manufacturing or shipping 1
Total Device Problems 1410

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 2 3 1 0 2 0 3 1 3 1
Class III 0 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 Dec-19-2016
10 Stanmore Implants Worldwide Ltd. II Aug-17-2016
11 Stryker Howmedica Osteonics Corp. II Sep-29-2010
12 Stryker Howmedica Osteonics Corp. II Apr-17-2009
13 Zimmer Biomet, Inc. II Jan-28-2017
14 Zimmer Inc. II Mar-09-2009
15 Zimmer, Inc. II Mar-20-2014
16 Zimmer, Inc. II Jan-17-2014

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