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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 16
BIOPRO, INC.
  1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 10
DOW
  2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  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.
  1
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Implant, removal of 667
Component(s), worn 380
Naturally worn 213
No Information 203
Loose 153
Unknown (for use when the device problem is not known) 126
Dislocated 84
Loss of or failure to bond 81
Loose or intermittent connection 39
Dislodged or dislocated 25
Other (for use when an appropriate device code cannot be identified) 24
Difficult to insert 23
No Known Device Problem 15
Loss of osseointegration 14
Fracture 14
Disassembly 14
Item contaminated during manufacturing or shipping 13
Migration of device or device component 11
Break 10
No code available 10
Malposition of device 9
Material integrity issue 6
Slippage of device or device component 6
Fitting problem 6
Failure to align 5
Positioning Issue 4
Unstable 4
Device remains implanted 4
Explanted 4
Component(s), broken 3
Device abrasion from instrument or another object 3
Scratched material 3
Unintended movement 2
Material Distortion 2
Patient-device incompatibility 2
Device operates differently than expected 2
Device packaging compromised 2
Noise, Audible 2
Metal shedding debris 2
Couple, failure to 2
Crack 2
Mechanical issue 2
Failure to Adhere or Bond 1
Instruction for use issue 1
Material discolored 1
Disengaged 1
Material erosion 1
Component missing 1
Incomplete or missing packaging 1
Device Issue 1
Material rigid or stiff 1
Size incorrect for patient 1
Sticking 1
Mislabeled 1
Pitted 1
User used incorrect product for intended use 1
Connection issue 1
Expiration date error 1
Malfunction 1
Incompatibility problem 1
Not Applicable 1
Total Device Problems 2215

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Jun-29-2011
2 Biomet, Inc. II Jun-15-2015
3 Biomet, Inc. II Jul-11-2013
4 Depuy Orthopaedics, Inc. II Jan-11-2007
5 Encore Medical, Lp II Oct-10-2007
6 Materialise USA LLC II Jan-03-2014
7 Stryker Howmedica Osteonics Corp. II Jan-12-2009
8 Zimmer, Inc. II Mar-20-2014

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