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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 987
No Known Device Problem 218
Fracture 201
Break 181
Material integrity issue 176
Unstable 107
No code available 106
Loose or intermittent connection 86
Manufacturing or shipping issue associated with device 83
Difficult to insert 80
Mechanical issue 75
Degraded 72
Migration of device or device component 71
Implant, removal of 63
Loss of osseointegration 54
Device operates differently than expected 54
Fitting problem 48
Loose 40
Malposition of device 39
Naturally worn 38
Failure to Adhere or Bond 38
Detachment of device component 38
Positioning Issue 30
Foreign material present in device 30
Dislodged or dislocated 29
Packaging issue 28
Slippage of device or device component 28
Component missing 24
Other (for use when an appropriate device code cannot be identified) 21
Use of Device Issue 20
Mechanical jam 18
Device damaged prior to use 18
Material discolored 17
Material disintegration 14
Loss of or failure to bond 14
Device packaging compromised 14
Residue after decontamination 13
Crack 13
Explanted 13
Unknown (for use when the device problem is not known) 13
Device remains implanted 13
Material deformation 12
Osseointegration issue 12
Scratched material 11
Noise, Audible 11
Melted 11
Improper or incorrect procedure or method 9
Sticking 9
Corrosion 9
Disassembly 9
Unintended movement 9
Tear, rip or hole in device packaging 9
Failure to align 9
Detachment of device or device component 9
Material fragmentation 8
Size incorrect for patient 8
Difficult to remove 8
Device, or device fragments remain in patient 7
Component(s), worn 7
Pitted 6
Difficult to position 6
Mechanics altered 6
Difficult to open or remove packaging material 5
Patient-device incompatibility 5
Nonstandard device or device component 5
Shipping damage or problem 4
Device inoperable 4
Metal shedding debris 4
Flaked 4
Device expiration issue 4
Connection issue 4
Incompatibility problem 4
Not Applicable 4
Torn material 3
Delamination 3
Device or device component damaged by another device 3
Device disinfection or sterilization issue 3
Defective item 3
Disconnection 3
Contamination during use 3
Failure to osseointegrate 3
Delivered as unsterile product 3
Unsealed device packaging 3
User used incorrect product for intended use 3
Peeled 2
Device abrasion from instrument or another object 2
Material separation 2
Component falling 2
Bent 2
Device Cleaning Issue 2
Dislocated 2
Disinfection or Sterilization Issue at User Location 2
Component or accessory incompatibility 2
Expiration date error 2
Difficult to open or close 2
Device handling issue 2
Material Distortion 1
Material Protrusion 1
Item contaminated during manufacturing or shipping 1
Human-Device Interface Issue 1
Total Device Problems 3518

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 2 0 0 1 0
Class II 0 0 1 0 2 1 0 0 5 6 1
Class III 0 0 1 0 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 MicroPort Orthopedics Inc. I Sep-08-2016
5 Stryker Howmedica Osteonics Corp. II Sep-13-2016
6 Stryker Howmedica Osteonics Corp. II Aug-11-2016
7 Stryker Howmedica Osteonics Corp. II Aug-14-2015
8 Stryker Howmedica Osteonics Corp. II Mar-16-2015
9 Stryker Howmedica Osteonics Corp. I Apr-12-2013
10 Stryker Howmedica Osteonics Corp. II Jan-08-2009
11 Wright Medical Technology Inc III Dec-08-2009
12 Zimmer Biomet, Inc. II Apr-25-2017
13 Zimmer Biomet, Inc. II Jun-07-2016
14 Zimmer Biomet, Inc. II Feb-22-2016
15 Zimmer Inc. II Jul-27-2012
16 Zimmer Inc. II May-10-2011
17 Zimmer Inc. II Apr-14-2011
18 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
19 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
20 Zimmer, Inc. II Mar-12-2015

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