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

Device Problems
Loss of or failure to bond 51
Loose 7
Implant, removal of 6
No Information 5
Loss of osseointegration 3
Malfunction 2
Migration of device or device component 2
No code available 2
Size incorrect for patient 1
Unknown (for use when the device problem is not known) 1
Fracture 1
Total Device Problems 81

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. II Jan-10-2007

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