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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 935
No Information 140
Loose 127
Implant, removal of 104
Loss of osseointegration 97
No code available 58
No Known Device Problem 47
Unknown (for use when the device problem is not known) 31
Failure to Adhere or Bond 25
Other (for use when an appropriate device code cannot be identified) 25
Break 24
Manufacturing or shipping issue associated with device 24
Malfunction 23
Device operates differently than expected 20
Loose or intermittent connection 18
Fracture 17
Tear, rip or hole in device packaging 12
Device damaged prior to use 12
Packaging issue 10
Device emits odor 9
Device packaging compromised 8
Leak 8
Slippage of device or device component 8
Unsealed device packaging 6
Device Difficult to Setup or Prepare 6
Shipping damage or problem 6
Dislodged or dislocated 5
Migration of device or device component 5
Device expiration issue 5
Moisture or humidity problem 5
Reaction 4
Fluid leak 4
Device handling issue 4
Foreign material 4
Patient-device incompatibility 4
Use of Device Issue 4
Delivered as unsterile product 4
Chemical issue 3
Failure to unwrap 3
Disassembly 3
Clumping in device or device ingredient 3
Improper or incorrect procedure or method 3
Incomplete or missing packaging 3
Application program issue 3
Difficult to open or remove packaging material 3
Component(s), worn 3
Difficult to insert 2
Absorption 2
Positioning Issue 2
Mechanical issue 2
Crack 2
Naturally worn 2
Device remains implanted 2
Material fragmentation 2
User used incorrect product for intended use 2
Foreign material present in device 2
Detachment of device component 2
Material integrity issue 2
Infusion or flow issue 2
Component missing 2
Coagulation in device or device ingredient 2
Bleed back 1
Particulates 1
Not Applicable 1
Sterility 1
Expiration date error 1
Fire 1
Unstable 1
Contamination during use 1
Osseointegration issue 1
Fibrosis 1
Defective component 1
Item contaminated during manufacturing or shipping 1
Device misassembled during manufacturing or shipping 1
Disengaged 1
Failure to deploy 1
Failure to separate 1
Fumes or vapors 1
Out-of-box failure 1
Device Issue 1
Mechanical jam 1
Use of Incorrect Control Settings 1
Explode 1
Shelf life exceeded 1
Ignited 1
Torn material 1
Malposition of device 1
Improper chemical reaction 1
Component falling 1
Total Device Problems 1933

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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