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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 916
No Information 133
Loose 127
Implant, removal of 104
Loss of osseointegration 95
No code available 57
No Known Device Problem 40
Unknown (for use when the device problem is not known) 31
Other (for use when an appropriate device code cannot be identified) 25
Manufacturing or shipping issue associated with device 24
Break 24
Failure to Adhere or Bond 24
Malfunction 23
Device operates differently than expected 20
Loose or intermittent connection 18
Fracture 16
Device damaged prior to use 12
Tear, rip or hole in device packaging 11
Device emits odor 9
Packaging issue 9
Leak 8
Device packaging compromised 8
Slippage of device or device component 8
Shipping damage or problem 6
Unsealed device packaging 6
Device Difficult to Setup or Prepare 6
Device expiration issue 5
Dislodged or dislocated 5
Moisture or humidity problem 5
Device handling issue 4
Patient-device incompatibility 4
Use of Device Issue 4
Fluid leak 4
Foreign material 4
Reaction 4
Migration of device or device component 4
Delivered as unsterile product 4
Disassembly 3
Component(s), worn 3
Clumping in device or device ingredient 3
Improper or incorrect procedure or method 3
Application program issue 3
Chemical issue 3
Difficult to open or remove packaging material 3
Incomplete or missing packaging 3
Failure to unwrap 3
Foreign material present in device 2
Infusion or flow issue 2
Component missing 2
Coagulation in device or device ingredient 2
Detachment of device component 2
Crack 2
Device remains implanted 2
User used incorrect product for intended use 2
Material fragmentation 2
Absorption 2
Difficult to insert 2
Naturally worn 2
Positioning Issue 2
Torn material 1
Not Applicable 1
Ignited 1
Mechanical issue 1
Shelf life exceeded 1
Particulates 1
Failure to deploy 1
Disengaged 1
Explode 1
Fire 1
Component falling 1
Contamination during use 1
Use of Incorrect Control Settings 1
Bleed back 1
Out-of-box failure 1
Device Issue 1
Expiration date error 1
Fumes or vapors 1
Failure to separate 1
Fibrosis 1
Malposition of device 1
Sterility 1
Unstable 1
Defective component 1
Item contaminated during manufacturing or shipping 1
Material integrity issue 1
Mechanical jam 1
Improper chemical reaction 1
Device misassembled during manufacturing or shipping 1
Total Device Problems 1889

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