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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 801
No Known Device Problem 198
Fracture 173
Break 163
Material integrity issue 160
No code available 102
Unstable 95
Loose or intermittent connection 83
Difficult to insert 76
Manufacturing or shipping issue associated with device 74
Degraded 69
Implant, removal of 63
Mechanical issue 59
Device operates differently than expected 55
Migration of device or device component 44
Fitting problem 42
Loose 40
Detachment of device component 37
Failure to Adhere or Bond 35
Malposition of device 33
Loss of osseointegration 30
Slippage of device or device component 28
Naturally worn 27
Foreign material present in device 26
Dislodged or dislocated 25
Packaging issue 22
Component missing 22
Positioning Issue 21
Other (for use when an appropriate device code cannot be identified) 21
Use of Device Issue 18
Material discolored 16
Device damaged prior to use 16
Mechanical jam 14
Material disintegration 14
Explanted 13
Crack 13
Unknown (for use when the device problem is not known) 13
Residue after decontamination 13
Device remains implanted 13
Loss of or failure to bond 12
Device packaging compromised 12
Melted 11
Disassembly 10
Material deformation 10
Detachment of device or device component 9
Failure to align 9
Scratched material 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
Material fragmentation 8
Noise, Audible 8
Unintended movement 7
Mechanics altered 7
Osseointegration issue 7
Component(s), worn 7
Device, or device fragments remain in patient 7
Nonstandard device or device component 5
Pitted 5
Difficult to open or remove packaging material 5
Incompatibility problem 4
Patient-device incompatibility 4
Connection issue 4
Metal shedding debris 4
Device inoperable 4
Device expiration issue 4
Flaked 4
Disconnection 3
Contamination during use 3
Failure to osseointegrate 3
Difficult to position 3
User used incorrect product for intended use 3
Delivered as unsterile product 3
Unsealed device packaging 3
Delamination 3
Defective item 3
Device disinfection or sterilization issue 3
Not Applicable 3
Torn material 3
Device handling issue 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
Peeled 2
Material separation 2
Shipping damage or problem 2
Bent 2
Component falling 2
Device Cleaning Issue 2
Dislocated 2
Entrapment of device or device component 1
Foreign material 1
Device abrasion from instrument or another object 1
Device maintenance issue 1
Collapse 1
Total Device Problems 3062

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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