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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 879
No Known Device Problem 206
Fracture 185
Break 174
Material integrity issue 170
No code available 103
Unstable 97
Loose or intermittent connection 85
Difficult to insert 79
Manufacturing or shipping issue associated with device 79
Degraded 69
Mechanical issue 66
Implant, removal of 63
Migration of device or device component 59
Device operates differently than expected 54
Fitting problem 44
Loose 40
Detachment of device component 37
Loss of osseointegration 37
Malposition of device 34
Failure to Adhere or Bond 34
Naturally worn 30
Foreign material present in device 29
Slippage of device or device component 28
Dislodged or dislocated 26
Positioning Issue 26
Packaging issue 23
Component missing 23
Other (for use when an appropriate device code cannot be identified) 21
Use of Device Issue 20
Material discolored 17
Device damaged prior to use 17
Mechanical jam 16
Device packaging compromised 14
Material disintegration 14
Explanted 13
Crack 13
Loss of or failure to bond 13
Unknown (for use when the device problem is not known) 13
Residue after decontamination 13
Device remains implanted 13
Melted 11
Material deformation 11
Scratched material 10
Detachment of device or device component 9
Failure to align 9
Corrosion 9
Tear, rip or hole in device packaging 9
Improper or incorrect procedure or method 9
Sticking 9
Size incorrect for patient 8
Difficult to remove 8
Disassembly 8
Material fragmentation 8
Noise, Audible 8
Unintended movement 7
Osseointegration issue 7
Component(s), worn 7
Device, or device fragments remain in patient 7
Mechanics altered 6
Patient-device incompatibility 5
Difficult to open or remove packaging material 5
Nonstandard device or device component 5
Pitted 5
Difficult to position 5
Metal shedding debris 4
Device inoperable 4
Device expiration issue 4
Flaked 4
Incompatibility problem 4
Connection issue 4
Not Applicable 4
Torn material 3
Delamination 3
Defective item 3
Device disinfection or sterilization issue 3
Disconnection 3
Contamination during use 3
Failure to osseointegrate 3
User used incorrect product for intended use 3
Delivered as unsterile product 3
Unsealed device packaging 3
Peeled 2
Material separation 2
Shipping damage or problem 2
Bent 2
Component falling 2
Device Cleaning Issue 2
Dislocated 2
Device abrasion from instrument or another object 2
Difficult to open or close 2
Device or device component damaged by another device 2
Expiration date error 2
Disinfection or Sterilization Issue at User Location 2
Component or accessory incompatibility 2
Device handling issue 2
Material Protrusion 1
Deployment issue 1
Contamination of device ingredient or reagent 1
Failure to cut 1
Total Device Problems 3251

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 0
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 Jun-07-2016
13 Zimmer Biomet, Inc. II Feb-22-2016
14 Zimmer Inc. II Jul-27-2012
15 Zimmer Inc. II May-10-2011
16 Zimmer Inc. II Apr-14-2011
17 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
18 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
19 Zimmer, Inc. II Mar-12-2015

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