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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 573
No Known Device Problem 143
Break 132
Material integrity issue 126
Fracture 125
No code available 91
Unstable 84
Loose or intermittent connection 78
Difficult to insert 66
Implant, removal of 63
Degraded 55
Manufacturing or shipping issue associated with device 50
Device operates differently than expected 49
Mechanical issue 45
Fitting problem 42
Loose 40
Detachment of device component 34
Failure to Adhere or Bond 30
Slippage of device or device component 28
Loss of osseointegration 26
Foreign material present in device 24
Naturally worn 23
Other (for use when an appropriate device code cannot be identified) 21
Malposition of device 19
Dislodged or dislocated 18
Migration of device or device component 18
Use of Device Issue 16
Device damaged prior to use 15
Component missing 15
Material discolored 15
Material disintegration 14
Explanted 13
Unknown (for use when the device problem is not known) 13
Residue after decontamination 13
Device remains implanted 13
Packaging issue 12
Positioning Issue 12
Device packaging compromised 11
Melted 11
Loss of or failure to bond 11
Crack 11
Corrosion 9
Disassembly 9
Mechanical jam 9
Failure to align 9
Detachment of device or device component 9
Material deformation 8
Improper or incorrect procedure or method 8
Difficult to remove 8
Tear, rip or hole in device packaging 8
Size incorrect for patient 8
Sticking 7
Device, or device fragments remain in patient 7
Component(s), worn 7
Unintended movement 7
Mechanics altered 6
Material fragmentation 6
Nonstandard device or device component 5
Pitted 5
Difficult to open or remove packaging material 5
Scratched material 5
Noise, Audible 4
Incompatibility problem 4
Device inoperable 4
Device expiration issue 4
Flaked 3
Disconnection 3
Contamination during use 3
Difficult to position 3
User used incorrect product for intended use 3
Delivered as unsterile product 3
Unsealed device packaging 3
Device disinfection or sterilization issue 3
Connection issue 3
Delamination 3
Patient-device incompatibility 3
Defective item 3
Disinfection or Sterilization Issue at User Location 2
Difficult to open or close 2
Device or device component damaged by another device 2
Torn material 2
Not Applicable 2
Peeled 2
Material separation 2
Metal shedding debris 2
Device Cleaning Issue 2
Dislocated 2
Entrapment of device or device component 1
Foreign material 1
Device maintenance issue 1
Device abrasion from instrument or another object 1
Misapplication 1
Collapse 1
Component(s), broken 1
Component falling 1
Application interface becomes non-functional or program exits abnormally 1
Difficult to deploy 1
Failure to osseointegrate 1
Vibration 1
Device stops intermittently 1
Total Device Problems 2428

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 4
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 Jun-07-2016
10 Zimmer Biomet, Inc. II Feb-22-2016
11 Zimmer Inc. II Jul-27-2012
12 Zimmer Inc. II May-10-2011
13 Zimmer Inc. II Apr-14-2011
14 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
15 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
16 Zimmer, Inc. II Mar-12-2015

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