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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Product CodeHRY
Regulation Number 888.3530
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 15
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 10
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
DOW
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Implant, removal of 667
Component(s), worn 380
Loose 153
Unknown (for use when the device problem is not known) 126
No Information 111
Dislocated 84
Loss of or failure to bond 69
Naturally worn 56
Loose or intermittent connection 25
Other (for use when an appropriate device code cannot be identified) 24
Fracture 13
Difficult to insert 10
Disassembly 10
Loss of osseointegration 9
No Known Device Problem 7
Dislodged or dislocated 6
Malposition of device 5
Migration of device or device component 5
Device remains implanted 4
Explanted 4
Break 4
Component(s), broken 3
Couple, failure to 2
No code available 2
Metal shedding debris 2
Fitting problem 2
Component missing 1
Incomplete or missing packaging 1
Device Issue 1
Unintended movement 1
Malfunction 1
Material discolored 1
Disengaged 1
Size incorrect for patient 1
Mislabeled 1
Pitted 1
User used incorrect product for intended use 1
Total Device Problems 1794

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 0 1 0 1 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Jun-29-2011
2 Depuy Orthopaedics, Inc. II Jan-11-2007
3 Encore Medical, Lp II Oct-10-2007
4 Stryker Howmedica Osteonics Corp. II Jan-12-2009

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