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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 4
DOW
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORP.
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 5
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
PORTLAND ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 13
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 21
SULZER
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1

Device Problems
No Information 17
Implant, removal of 6
Fitting problem 6
Loose 5
Metal shedding debris 5
Unknown (for use when the device problem is not known) 5
Device remains implanted 5
Explanted 4
No code available 4
Defective component 4
Tear, rip or hole in device packaging 3
Loss of osseointegration 3
Detachment of device component 3
Sticking 3
Dislodged or dislocated 3
Break 3
Fracture 3
Dislocated 2
Foreign material 2
Noise 2
Difficult to insert 2
Loose or intermittent connection 2
Malposition of device 2
Loss of or failure to bond 2
Device expiration issue 1
Defective item 1
Contamination during use 1
Corrosion 1
Disengaged 1
Displacement 1
Seal, incorrect 1
Device damaged prior to use 1
Design/structure problem 1
Material separation 1
Migration of device or device component 1
Total Device Problems 107

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

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

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