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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Product CodeMBH
Regulation Number 888.3565
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 13
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 2
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 2
OMNI
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 15
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 8
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
No Information 518
Break 127
No Known Device Problem 123
Fracture 122
Material integrity issue 106
No code available 91
Unstable 84
Loose or intermittent connection 78
Difficult to insert 66
Implant, removal of 63
Degraded 48
Device operates differently than expected 47
Manufacturing or shipping issue associated with device 44
Mechanical issue 43
Loose 40
Fitting problem 40
Detachment of device component 32
Slippage of device or device component 28
Failure to Adhere or Bond 27
Loss of osseointegration 24
Foreign material present in device 23
Naturally worn 23
Other (for use when an appropriate device code cannot be identified) 21
Dislodged or dislocated 18
Malposition of device 16
Migration of device or device component 15
Material discolored 15
Material disintegration 14
Use of Device Issue 14
Unknown (for use when the device problem is not known) 13
Device damaged prior to use 13
Residue after decontamination 13
Device remains implanted 13
Explanted 13
Packaging issue 12
Positioning Issue 11
Device packaging compromised 11
Melted 11
Loss of or failure to bond 11
Crack 10
Disassembly 10
Component missing 10
Failure to align 9
Detachment of device or device component 9
Mechanical jam 9
Material deformation 8
Tear, rip or hole in device packaging 8
Size incorrect for patient 8
Difficult to remove 8
Device, or device fragments remain in patient 7
Sticking 7
Improper or incorrect procedure or method 7
Component(s), worn 7
Unintended movement 7
Mechanics altered 6
Material fragmentation 6
Nonstandard device or device component 5
Scratched material 5
Difficult to open or remove packaging material 5
Noise, Audible 4
Device expiration issue 4
Device inoperable 4
Pitted 4
Difficult to position 3
User used incorrect product for intended use 3
Flaked 3
Delivered as unsterile product 3
Unsealed device packaging 3
Contamination during use 3
Disconnection 3
Connection issue 3
Delamination 3
Patient-device incompatibility 3
Disinfection or Sterilization Issue at User Location 2
Defective item 2
Device or device component damaged by another device 2
Device disinfection or sterilization issue 2
Difficult to open or close 2
Incompatibility problem 2
Torn material 2
Not Applicable 2
Device Cleaning Issue 2
Peeled 2
Dislocated 2
Material separation 2
Metal shedding debris 2
Failure to osseointegrate 1
Device stops intermittently 1
Vibration 1
Dull 1
Out-of-box failure 1
Inadequate service 1
Shelf life exceeded 1
Shipping damage or problem 1
Material rigid or stiff 1
Material rupture 1
Product quality issue 1
Misapplication 1
Entrapment of device or device component 1
Foreign material 1
Total Device Problems 2268

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 2 0 0 0
Class II 0 0 1 0 2 1 0 0 5 2
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-25-2016
2 DePuy Orthopaedics, Inc. II Jul-20-2015
3 DePuy Orthopaedics, Inc. I Feb-15-2013
4 Stryker Howmedica Osteonics Corp. II Aug-14-2015
5 Stryker Howmedica Osteonics Corp. II Mar-16-2015
6 Stryker Howmedica Osteonics Corp. I Apr-12-2013
7 Stryker Howmedica Osteonics Corp. II Jan-08-2009
8 Wright Medical Technology Inc III Dec-08-2009
9 Zimmer Biomet, Inc. II Feb-22-2016
10 Zimmer Inc. II Jul-27-2012
11 Zimmer Inc. II May-10-2011
12 Zimmer Inc. II Apr-14-2011
13 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
14 Zimmer, Inc. II Mar-12-2015

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