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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
  1.  K020741  UNICONDYLAR KNEE
  2.  K022437  UNI KNEE
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 257
No Information 229
Loose 153
Unknown (for use when the device problem is not known) 126
Dislocated 84
Loss of or failure to bond 82
Loose or intermittent connection 41
Dislodged or dislocated 34
Other (for use when an appropriate device code cannot be identified) 24
Difficult to insert 23
No Known Device Problem 17
Fracture 16
Break 16
Disassembly 15
Loss of osseointegration 14
Item contaminated during manufacturing or shipping 13
No code available 13
Migration of device or device component 12
Unstable 11
Malposition of device 10
Material integrity issue 8
Fitting problem 7
Slippage of device or device component 6
Positioning Issue 6
Failure to align 5
Device remains implanted 4
Explanted 4
Component(s), broken 3
Mechanical issue 3
Device abrasion from instrument or another object 3
Scratched material 3
Noise, Audible 3
Unintended movement 2
Device operates differently than expected 2
Device packaging compromised 2
Material Distortion 2
Patient-device incompatibility 2
Metal shedding debris 2
Couple, failure to 2
Crack 2
Degraded 1
Material discolored 1
Disengaged 1
Failure to Adhere or Bond 1
Material erosion 1
Instruction for use issue 1
Sticking 1
Component missing 1
Incomplete or missing packaging 1
Material rigid or stiff 1
Size incorrect for patient 1
Mislabeled 1
Pitted 1
User used incorrect product for intended use 1
Connection issue 1
Device markings issue 1
Malfunction 1
Device Issue 1
Incompatibility problem 1
Expiration date error 1
Not Applicable 1
Total Device Problems 2329

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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