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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone cement
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeLOD
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 7
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 9
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 5
IMMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Loss of or failure to bond 1086
No Information 192
Loose 127
Loss of osseointegration 117
Implant, removal of 104
No code available 65
No Known Device Problem 59
Break 32
Unknown (for use when the device problem is not known) 31
Failure to Adhere or Bond 29
Manufacturing or shipping issue associated with device 28
Other (for use when an appropriate device code cannot be identified) 25
Malfunction 23
Device operates differently than expected 21
Loose or intermittent connection 19
Fracture 18
Migration of device or device component 18
Tear, rip or hole in device packaging 18
Shipping damage or problem 16
Unsealed device packaging 14
Device emits odor 12
Device damaged prior to use 12
Packaging issue 12
Device handling issue 9
Device packaging compromised 8
Use of Device Issue 8
Slippage of device or device component 8
Leak 8
Device Difficult to Setup or Prepare 6
Delivered as unsterile product 6
Osseointegration issue 6
Moisture or humidity problem 5
Material integrity issue 5
Dislodged or dislocated 5
Clumping in device or device ingredient 5
Device expiration issue 5
Improper or incorrect procedure or method 5
Inadequate training 4
Reaction 4
Patient-device incompatibility 4
Disassembly 4
Fluid leak 4
Foreign material 4
Mechanical issue 3
Component(s), worn 3
Crack 3
Application program issue 3
Chemical issue 3
Incomplete or missing packaging 3
Component missing 3
Sticking 3
Unstable 3
Failure to unwrap 3
Foreign material present in device 3
Difficult to open or remove packaging material 3
Improper chemical reaction 2
Infusion or flow issue 2
Naturally worn 2
Positioning Issue 2
Torn material 2
Device remains implanted 2
Malposition of device 2
Coagulation in device or device ingredient 2
Detachment of device component 2
User used incorrect product for intended use 2
Material fragmentation 2
Absorption 2
Difficult to insert 2
Ignited 1
Particulates 1
Component falling 1
Bleed back 1
Charred 1
Failure to deploy 1
Contamination during use 1
Use of Incorrect Control Settings 1
Disengaged 1
Explode 1
Fire 1
Device Issue 1
Device misassembled during manufacturing or shipping 1
Out-of-box failure 1
Expiration date error 1
Fumes or vapors 1
Split 1
Failure to separate 1
Fibrosis 1
Material separation 1
Shelf life exceeded 1
Sterility 1
Defective component 1
Material perforation 1
Not Applicable 1
Item contaminated during manufacturing or shipping 1
Mechanical jam 1
Total Device Problems 2280

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Aug-19-2016
2 Zimmer Biomet, Inc. II Apr-25-2017
3 Zimmer, Inc. II Dec-31-2014

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