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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 230
No Information 230
Fracture 133
Break 102
Implant, removal of 64
Dislodged or dislocated 56
Migration of device or device component 54
Disassembly 50
Unknown (for use when the device problem is not known) 41
No code available 37
Naturally worn 36
Loose or intermittent connection 32
Unstable 26
Tear, rip or hole in device packaging 22
Explanted 22
Device operates differently than expected 21
Detachment of device or device component 20
Mechanical issue 20
Failure to Adhere or Bond 20
Component(s), broken 19
Packaging issue 19
Loose 18
Detachment of device component 17
Component missing 16
Material integrity issue 15
Loss of or failure to bond 12
Unintended movement 11
Incorrect device or component shipped 11
Manufacturing or shipping issue associated with device 10
Loss of osseointegration 10
Device damaged prior to use 8
Difficult to insert 8
Device packaging compromised 8
Patient-device incompatibility 6
Fitting problem 6
Size incorrect for patient 6
Use of Device Issue 5
Improper or incorrect procedure or method 5
Source, incorrect 5
Out-of-box failure 5
Device Issue 5
Material erosion 5
Degraded 5
Device markings issue 5
Item contaminated during manufacturing or shipping 5
Component or accessory incompatibility 4
Noise, Audible 4
Delivered as unsterile product 4
Defective component 4
Other (for use when an appropriate device code cannot be identified) 3
Malfunction 3
Shipping damage or problem 3
Product quality issue 3
Instruction for use issue 3
Dislocated 3
Component(s), worn 3
Component incompatible 3
Corrosion 3
Failure to expand 3
Malposition of device 3
Incompatibility problem 3
Device-device incompatibility 3
Foreign material present in device 2
Failure to separate 2
Positioning Issue 2
Device Cleaning Issue 2
Crack 2
Material fragmentation 2
Device remains implanted 2
Shelf life exceeded 2
Slippage of device or device component 2
Device inoperable 2
Inaccurate delivery 2
Incomplete or missing packaging 2
Device contamination with blood or blood product 1
Automatic injection system underinfusion 1
Residue after decontamination 1
Failure to align 1
Metal shedding debris 1
Sterility 1
Failure to sterilize 1
Device stops intermittently 1
Difficult to remove 1
Replace 1
Flaked 1
Insulation degradation 1
Unsealed device packaging 1
Pitted 1
Difficult to position 1
Misassembled 1
Failure to deploy 1
Entrapment of device or device component 1
Disconnection 1
Disengaged 1
Bent 1
Couple, failure to 1
Torn material 1
Mechanical jam 1
Not Applicable 1
Device displays error message 1
Total Device Problems 1566

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 4
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 Medacta Usa Inc II Jun-12-2017
9 Onkos Surgical, Inc. II Jun-29-2017
10 Smith & Nephew, Inc. II Jun-29-2016
11 Stanmore Implants Worldwide Ltd. II Dec-19-2016
12 Stanmore Implants Worldwide Ltd. II Aug-17-2016
13 Stryker Howmedica Osteonics Corp. II Sep-29-2010
14 Stryker Howmedica Osteonics Corp. II Apr-17-2009
15 Zimmer Biomet, Inc. II Mar-20-2017
16 Zimmer Biomet, Inc. II Jan-28-2017
17 Zimmer Inc. II Mar-09-2009
18 Zimmer, Inc. II Mar-20-2014
19 Zimmer, Inc. II Jan-17-2014

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