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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 139
Implant, removal of 54
Dislodged or dislocated 46
Unknown (for use when the device problem is not known) 35
Dislocated 13
No code available 5
Metal shedding debris 3
Naturally worn 3
No Known Device Problem 3
Other (for use when an appropriate device code cannot be identified) 1
Migration of device or device component 1
Size incorrect for patient 1
Total Device Problems 304

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