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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 145
Infusion or flow issue 118
Loss of or failure to bond 60
No Information 26
No flow 14
Device packaging compromised 13
No code available 12
Loose 7
Device operates differently than expected 6
Implant, removal of 6
Tear, rip or hole in device packaging 6
Loss of osseointegration 5
Contamination during use 3
Migration of device or device component 3
Manufacturing or shipping issue associated with device 3
No Known Device Problem 2
Sediment, precipitate or deposit in device or device ingredient 2
Malfunction 2
Device expiration issue 1
Fracture 1
Break 1
Shelf life exceeded 1
Shipping damage or problem 1
Size incorrect for patient 1
Slippage of device or device component 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
Temperature issue 1
Packaging issue 1
Device emits odor 1
Failure to Adhere or Bond 1
Foreign material present in device 1
Improper chemical reaction 1
Improper flow or infusion 1
Total Device Problems 451

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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