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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.
Product CodeOIY
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Information 91
Failure to Adhere or Bond 70
No code available 21
Unstable 17
Device operates differently than expected 8
No Known Device Problem 7
Difficult to insert 5
Migration of device or device component 4
Nonstandard device or device component 3
Malposition of device 3
Loose or intermittent connection 2
Size incorrect for patient 1
Loss of or failure to bond 1
Break 1
Disassembly 1
Dislodged or dislocated 1
Foreign material present in device 1
Total Device Problems 237

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 1 1 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Oct-26-2015
2 Encore Medical, Lp II May-02-2013
3 Encore Medical, Lp II Aug-30-2012
4 Zimmer, Inc. II Feb-04-2015

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