• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeMEH
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 4
BIOMET
  SUBSTANTIALLY EQUIVALENT 6
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 5
DOW
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORP.
  1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 5
IMPLEX
  1
  SUBSTANTIALLY EQUIVALENT 1
JOINT MEDICAL PRODUCTS CORP.
  1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
PORTLAND ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 13
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 21
SULZER
  1
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 235
No Known Device Problem 56
Dislodged or dislocated 56
Material integrity issue 48
Fracture 44
No code available 29
Mechanical issue 27
Break 24
Naturally worn 23
Loose or intermittent connection 19
Degraded 18
Malposition of device 18
Loss of osseointegration 17
Metal shedding debris 15
Detachment of device component 15
Fitting problem 14
Positioning Issue 13
Migration of device or device component 11
Slippage of device or device component 10
Corrosion 9
Material deformation 9
Device operates differently than expected 8
Material erosion 8
Device-device incompatibility 7
Implant, removal of 7
Unstable 7
Not Applicable 7
Manufacturing or shipping issue associated with device 6
Sticking 6
Loose 5
Device remains implanted 5
Defective component 5
Unknown (for use when the device problem is not known) 5
Noise, Audible 5
Osseointegration issue 4
Packaging issue 4
Tear, rip or hole in device packaging 4
Use of Device Issue 4
Explanted 4
Loss of or failure to bond 4
Size incorrect for patient 3
Defective item 3
Detachment of device or device component 3
Foreign material present in device 3
Incompatibility problem 3
Item contaminated during manufacturing or shipping 2
Device packaging compromised 2
Patient-device incompatibility 2
Noise 2
Loss of power 2
Material separation 2
Failure to Adhere or Bond 2
Component falling 2
Contamination during use 2
Dislocated 2
Disassembly 2
Foreign material 2
Difficult to insert 2
Difficult to remove 2
Material Protrusion 2
Scratched material 2
Unintended movement 1
Seal, incorrect 1
Incorrect measurement 1
Unexpected therapeutic results 1
Device inoperable 1
Nonstandard device or device component 1
Unsealed device packaging 1
Material discolored 1
Disengaged 1
Design/structure problem 1
Displacement 1
Device expiration issue 1
Accessory incompatible 1
Improper or incorrect procedure or method 1
Device displays error message 1
Failure to disconnect 1
Device damaged prior to use 1
Disinfection or Sterilization Issue at User Location 1
Contamination of device ingredient or reagent 1
Device or device component damaged by another device 1
Total Device Problems 882

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 2 2 4 1 3 4 4 1 3 2 1
Class III 0 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Depuy Orthopaedics Inc. II Nov-21-2016
2 Exactech, Inc. II Nov-02-2015
3 Medacta Usa Inc II Feb-23-2013
4 Medacta Usa Inc II Feb-07-2013
5 Medacta Usa Inc II Jun-30-2011
6 Portland Orthopaedics Pty, Ltd. II Sep-18-2008
7 Smith & Nephew Inc II Sep-20-2012
8 Smith & Nephew, Inc. II Jan-04-2017
9 Smith & Nephew, Inc. II Jul-28-2016
10 Stryker Howmedica Osteonics Corp. II Feb-03-2015
11 Stryker Howmedica Osteonics Corp. II Apr-02-2014
12 Stryker Howmedica Osteonics Corp. II Jan-08-2013
13 Stryker Howmedica Osteonics Corp. II Jul-26-2012
14 Stryker Howmedica Osteonics Corp. II May-29-2012
15 Stryker Howmedica Osteonics Corp. II Jan-30-2012
16 Stryker Howmedica Osteonics Corp. II Oct-20-2011
17 Stryker Howmedica Osteonics Corp. II Feb-07-2011
18 Stryker Howmedica Osteonics Corp. II Apr-19-2010
19 Stryker Howmedica Osteonics Corp. II Dec-22-2009
20 Stryker Howmedica Osteonics Corp. III Sep-14-2009
21 Stryker Howmedica Osteonics Corp. II Aug-13-2009
22 Stryker Howmedica Osteonics Corp. II Jul-22-2009
23 Stryker Howmedica Osteonics Corp. II Jan-26-2009
24 Stryker Howmedica Osteonics Corp. II Jun-12-2008
25 Stryker Howmedica Osteonics Corp. II Oct-25-2007
26 Stryker Howmedica Osteonics Corp. II Sep-26-2007
27 Zimmer Gmbh II Feb-20-2015
28 Zimmer, Inc. II Feb-04-2013

-
-