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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 5
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unsealed device packaging 236
Infusion or flow issue 148
Loss of or failure to bond 68
No Information 34
No code available 15
Device packaging compromised 15
No flow 14
Failure to Adhere or Bond 10
Device operates differently than expected 8
Tear, rip or hole in device packaging 7
Loose 7
Migration of device or device component 7
Implant, removal of 6
Improper chemical reaction 6
Loss of osseointegration 5
Manufacturing or shipping issue associated with device 3
Contamination during use 3
Shipping damage or problem 3
No Known Device Problem 3
Sediment, precipitate or deposit in device or device ingredient 2
Device handling issue 2
Improper flow or infusion 2
Malfunction 2
Break 2
Precipitate in device or device ingredient 2
Shelf life exceeded 1
Chemical issue 1
Dislodged or dislocated 1
Foreign material present in device 1
Size incorrect for patient 1
Slippage of device or device component 1
Inadequate training 1
Unstable 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Incomplete or missing packaging 1
Crack 1
Device expiration issue 1
Fire 1
Fracture 1
Device emits odor 1
Overheating of device or device component 1
Temperature issue 1
Torn material 1
Packaging issue 1
Total Device Problems 630

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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