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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 986
No Information 162
Loose 127
Implant, removal of 104
Loss of osseointegration 101
No code available 62
No Known Device Problem 49
Unknown (for use when the device problem is not known) 31
Break 29
Manufacturing or shipping issue associated with device 27
Failure to Adhere or Bond 26
Other (for use when an appropriate device code cannot be identified) 25
Malfunction 23
Device operates differently than expected 18
Loose or intermittent connection 18
Fracture 18
Tear, rip or hole in device packaging 14
Unsealed device packaging 13
Device damaged prior to use 12
Packaging issue 11
Device emits odor 9
Shipping damage or problem 8
Slippage of device or device component 8
Device packaging compromised 8
Leak 8
Device handling issue 8
Migration of device or device component 6
Device Difficult to Setup or Prepare 6
Use of Device Issue 6
Improper or incorrect procedure or method 5
Dislodged or dislocated 5
Delivered as unsterile product 5
Clumping in device or device ingredient 5
Device expiration issue 5
Moisture or humidity problem 5
Material integrity issue 4
Fluid leak 4
Foreign material 4
Disassembly 4
Reaction 4
Patient-device incompatibility 4
Inadequate training 4
Incomplete or missing packaging 3
Application program issue 3
Chemical issue 3
Failure to unwrap 3
Difficult to open or remove packaging material 3
Mechanical issue 3
Crack 3
Component(s), worn 3
Coagulation in device or device ingredient 2
Detachment of device component 2
Material fragmentation 2
Absorption 2
Difficult to insert 2
Device remains implanted 2
User used incorrect product for intended use 2
Infusion or flow issue 2
Foreign material present in device 2
Component missing 2
Naturally worn 2
Positioning Issue 2
Malposition of device 2
Osseointegration issue 1
Torn material 1
Not Applicable 1
Mechanical jam 1
Out-of-box failure 1
Defective component 1
Device Issue 1
Unstable 1
Sterility 1
Improper chemical reaction 1
Item contaminated during manufacturing or shipping 1
Device misassembled during manufacturing or shipping 1
Expiration date error 1
Fumes or vapors 1
Failure to separate 1
Fibrosis 1
Shelf life exceeded 1
Particulates 1
Ignited 1
Component falling 1
Contamination during use 1
Use of Incorrect Control Settings 1
Bleed back 1
Failure to deploy 1
Disengaged 1
Explode 1
Fire 1
Total Device Problems 2058

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 0
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, Inc. II Dec-31-2014

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