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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone cement, antibiotic
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeMBB
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unsealed device packaging 134
Infusion or flow issue 116
Loss of or failure to bond 59
No Information 22
No flow 14
Device packaging compromised 13
No code available 11
Loose 7
Implant, removal of 6
Device operates differently than expected 6
Tear, rip or hole in device packaging 6
Loss of osseointegration 5
Manufacturing or shipping issue associated with device 3
Contamination during use 3
Migration of device or device component 3
Sediment, precipitate or deposit in device or device ingredient 2
No Known Device Problem 2
Malfunction 2
Device damaged prior to use 1
Improper chemical reaction 1
Break 1
Shelf life exceeded 1
Slippage of device or device component 1
Packaging issue 1
Temperature issue 1
Device expiration issue 1
Improper flow or infusion 1
Size incorrect for patient 1
Foreign material present in device 1
Device emits odor 1
Incomplete or missing packaging 1
Shipping damage or problem 1
Unknown (for use when the device problem is not known) 1
Fracture 1
Failure to Adhere or Bond 1
Unstable 1
Total Device Problems 432

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 1 0 0 0 0 0 1 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-05-2015
2 DePuy Orthopaedics, Inc. II Oct-23-2013
3 Stryker Howmedica Osteonics Corp. II Jan-10-2007
4 Zimmer, Inc. II Jan-13-2014

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