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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 701
Loose 127
Implant, removal of 104
No Information 90
Loss of osseointegration 77
Unknown (for use when the device problem is not known) 31
No code available 31
No Known Device Problem 30
Other (for use when an appropriate device code cannot be identified) 25
Malfunction 23
Break 19
Loose or intermittent connection 18
Device operates differently than expected 18
Manufacturing or shipping issue associated with device 16
Fracture 16
Device damaged prior to use 11
Tear, rip or hole in device packaging 10
Device emits odor 9
Leak 8
Packaging issue 8
Slippage of device or device component 8
Device packaging compromised 7
Failure to Adhere or Bond 6
Moisture or humidity problem 5
Device expiration issue 4
Fluid leak 4
Foreign material 4
Unsealed device packaging 4
Delivered as unsterile product 4
Reaction 4
Migration of device or device component 3
Disassembly 3
Clumping in device or device ingredient 3
Component(s), worn 3
Difficult to open or remove packaging material 3
Dislodged or dislocated 3
Failure to unwrap 3
Patient-device incompatibility 3
Application program issue 3
Chemical issue 3
Incomplete or missing packaging 3
Use of Device Issue 3
Shipping damage or problem 3
Improper or incorrect procedure or method 2
Positioning Issue 2
Foreign material present in device 2
Coagulation in device or device ingredient 2
Device remains implanted 2
Device Difficult to Setup or Prepare 2
User used incorrect product for intended use 2
Material fragmentation 2
Absorption 2
Difficult to insert 2
Device handling issue 2
Infusion or flow issue 2
Naturally worn 1
Ignited 1
Mechanical issue 1
Shelf life exceeded 1
Particulates 1
Detachment of device component 1
Component falling 1
Contamination during use 1
Use of Incorrect Control Settings 1
Crack 1
Failure to deploy 1
Disengaged 1
Bleed back 1
Explode 1
Fire 1
Improper chemical reaction 1
Device misassembled during manufacturing or shipping 1
Torn material 1
Not Applicable 1
Material integrity issue 1
Mechanical jam 1
Sterility 1
Unstable 1
Defective component 1
Component missing 1
Out-of-box failure 1
Device Issue 1
Expiration date error 1
Fibrosis 1
Malposition of device 1
Total Device Problems 1515

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 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer, Inc. II Dec-31-2014

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