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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 132
No Known Device Problem 42
Material integrity issue 42
Fracture 35
Dislodged or dislocated 27
No code available 24
Loose or intermittent connection 19
Naturally worn 18
Mechanical issue 16
Break 16
Degraded 16
Metal shedding debris 13
Fitting problem 13
Malposition of device 12
Detachment of device component 11
Loss of osseointegration 10
Slippage of device or device component 9
Migration of device or device component 9
Device operates differently than expected 8
Device-device incompatibility 7
Material deformation 7
Unstable 7
Implant, removal of 7
Positioning Issue 7
Sticking 6
Manufacturing or shipping issue associated with device 6
Material erosion 6
Corrosion 5
Loose 5
Device remains implanted 5
Unknown (for use when the device problem is not known) 5
Defective component 5
Tear, rip or hole in device packaging 4
Explanted 4
Loss of or failure to bond 4
Packaging issue 4
Not Applicable 3
Size incorrect for patient 3
Use of Device Issue 3
Defective item 3
Foreign material present in device 3
Incompatibility problem 3
Item contaminated during manufacturing or shipping 2
Detachment of device or device component 2
Patient-device incompatibility 2
Noise 2
Loss of power 2
Difficult to remove 2
Foreign material 2
Difficult to insert 2
Failure to Adhere or Bond 2
Component falling 2
Dislocated 2
Noise, Audible 2
Scratched material 2
Unintended movement 1
Osseointegration issue 1
Displacement 1
Device expiration issue 1
Design/structure problem 1
Disassembly 1
Material discolored 1
Disengaged 1
Contamination during use 1
Accessory incompatible 1
Nonstandard device or device component 1
Unsealed device packaging 1
Seal, incorrect 1
Material separation 1
Incorrect measurement 1
Device damaged prior to use 1
Failure to disconnect 1
Improper or incorrect procedure or method 1
Unexpected therapeutic results 1
Device inoperable 1
Contamination of device ingredient or reagent 1
Device packaging compromised 1
Material Protrusion 1
Total Device Problems 633

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 2 4 1 3 4 4 1 3 0
Class III 0 0 1 0 0 0 0 0 0 0

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

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