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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 119
No Information 118
Fracture 93
Break 70
Implant, removal of 64
Unknown (for use when the device problem is not known) 41
Disassembly 39
Dislodged or dislocated 39
No code available 30
Naturally worn 24
Loose or intermittent connection 23
Explanted 22
Migration of device or device component 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 16
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
Component missing 10
Material integrity issue 9
Unintended movement 6
Manufacturing or shipping issue associated with device 6
Device packaging compromised 6
Fitting problem 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
Loss of osseointegration 5
Patient-device incompatibility 5
Item contaminated during manufacturing or shipping 5
Device markings issue 4
Out-of-box failure 4
Improper or incorrect procedure or method 4
Other (for use when an appropriate device code cannot be identified) 3
Defective component 3
Malfunction 3
Device Issue 3
Malposition of device 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
Device inoperable 2
Inaccurate delivery 2
Failure to separate 2
Slippage of device or device component 2
Shelf life exceeded 2
Shipping damage or problem 1
Sterility 1
Failure to sterilize 1
Device stops intermittently 1
Automatic injection system underinfusion 1
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
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 1082

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 1
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 Stryker Howmedica Osteonics Corp. II Sep-29-2010
10 Stryker Howmedica Osteonics Corp. II Apr-17-2009
11 Zimmer Inc. II Mar-09-2009
12 Zimmer, Inc. II Mar-20-2014
13 Zimmer, Inc. II Jan-17-2014

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