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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
Regulation Description Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Definition For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Product CodePBI
Regulation Number 888.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component or accessory incompatibility 43
Fracture 33
Dislodged or dislocated 13
No Information 13
Break 12
Device-device incompatibility 10
Migration of device or device component 7
Failure to separate 5
Fitting problem 3
Accessory incompatible 3
Malposition of device 2
Detachment of device or device component 2
Device operates differently than expected 2
Positioning Issue 2
Scratched material 1
No Known Device Problem 1
Packaging issue 1
Difficult to insert 1
Size incorrect for patient 1
Sticking 1
Metal shedding debris 1
Total Device Problems 157

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jun-19-2014

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