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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, hemi-, femoral, metal ball
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeLZY
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 206
Dislodged or dislocated 60
Implant, removal of 54
Unknown (for use when the device problem is not known) 35
Dislocated 13
No code available 12
No Known Device Problem 5
Naturally worn 3
Size incorrect for patient 2
Metal shedding debris 1
Other (for use when an appropriate device code cannot be identified) 1
Migration of device or device component 1
Break 1
Disassembly 1
Total Device Problems 395

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

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew Inc II Sep-24-2009

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