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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
Infusion or flow issue 68
Loss of or failure to bond 56
Unsealed device packaging 38
No Information 12
Device packaging compromised 12
No flow 11
No code available 10
Loose 7
Implant, removal of 6
Tear, rip or hole in device packaging 6
Loss of osseointegration 5
Device operates differently than expected 4
Contamination during use 3
Malfunction 2
Migration of device or device component 2
No Known Device Problem 2
Sediment, precipitate or deposit in device or device ingredient 2
Temperature issue 1
Device emits odor 1
Foreign material present in device 1
Improper flow or infusion 1
Manufacturing or shipping issue associated with device 1
Device expiration issue 1
Fracture 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
Total Device Problems 260

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