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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 591
No Known Device Problem 153
Break 133
Material integrity issue 131
Fracture 129
No code available 92
Unstable 84
Loose or intermittent connection 78
Difficult to insert 70
Implant, removal of 63
Degraded 56
Manufacturing or shipping issue associated with device 54
Device operates differently than expected 49
Mechanical issue 44
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 27
Foreign material present in device 25
Naturally worn 24
Other (for use when an appropriate device code cannot be identified) 21
Migration of device or device component 21
Dislodged or dislocated 20
Malposition of device 18
Use of Device Issue 16
Device damaged prior to use 15
Component missing 15
Material discolored 15
Material disintegration 14
Packaging issue 14
Explanted 13
Unknown (for use when the device problem is not known) 13
Residue after decontamination 13
Device remains implanted 13
Positioning Issue 12
Device packaging compromised 12
Melted 11
Crack 11
Loss of or failure to bond 11
Mechanical jam 10
Material deformation 9
Failure to align 9
Detachment of device or device component 9
Corrosion 9
Disassembly 9
Difficult to remove 8
Tear, rip or hole in device packaging 8
Size incorrect for patient 8
Improper or incorrect procedure or method 8
Unintended movement 7
Sticking 7
Device, or device fragments remain in patient 7
Component(s), worn 7
Material fragmentation 6
Mechanics altered 6
Difficult to open or remove packaging material 5
Scratched material 5
Nonstandard device or device component 5
Pitted 5
Device inoperable 4
Device expiration issue 4
Noise, Audible 4
Incompatibility problem 4
Patient-device incompatibility 4
Defective item 3
Device disinfection or sterilization issue 3
Connection issue 3
Delamination 3
Torn material 3
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
Peeled 2
Shipping damage or problem 2
Material separation 2
Metal shedding debris 2
Device Cleaning Issue 2
Dislocated 2
Not Applicable 2
Disinfection or Sterilization Issue at User Location 2
Expiration date error 2
Difficult to open or close 2
Device or device component damaged by another device 2
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
Material Protrusion 1
Failure to cut 1
Malfunction 1
Sharp/jagged/rough/etched/scratched 1
Deployment issue 1
Contamination of device ingredient or reagent 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Device Contamination with biological material 1
Total Device Problems 2491

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 5
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-11-2016
5 Stryker Howmedica Osteonics Corp. II Aug-14-2015
6 Stryker Howmedica Osteonics Corp. II Mar-16-2015
7 Stryker Howmedica Osteonics Corp. I Apr-12-2013
8 Stryker Howmedica Osteonics Corp. II Jan-08-2009
9 Wright Medical Technology Inc III Dec-08-2009
10 Zimmer Biomet, Inc. II Jun-07-2016
11 Zimmer Biomet, Inc. II Feb-22-2016
12 Zimmer Inc. II Jul-27-2012
13 Zimmer Inc. II May-10-2011
14 Zimmer Inc. II Apr-14-2011
15 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
16 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
17 Zimmer, Inc. II Mar-12-2015

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