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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, metal/polymer, cemented
Regulation Description Hip joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJDI
Regulation Number 888.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  4
  SUBSTANTIALLY EQUIVALENT 49
BIOPRO, INC.
  3
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  17
  SUBSTANTIALLY EQUIVALENT 35
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  1
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL CORPORATION
  1
  SUBSTANTIALLY EQUIVALENT 12
EXACTECH, INC.
  2
  SUBSTANTIALLY EQUIVALENT 10
IMPLEX
  SUBSTANTIALLY EQUIVALENT 10
JOHNSON & JOHNSON
  4
  SUBSTANTIALLY EQUIVALENT 5
JOINT MEDICAL PRODUCTS CORP.
  2
  SUBSTANTIALLY EQUIVALENT 6
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
MACROPORE BIOSURGERY
  SE - WITH LIMITATIONS 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SE - WITH LIMITATIONS 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 4
ORTHOPEDIC SYSTEMS, INC.
  3
  SUBSTANTIALLY EQUIVALENT 4
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 6
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 8
STELKAST
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  2
  SUBSTANTIALLY EQUIVALENT 24
SULZER
  SUBSTANTIALLY EQUIVALENT 3
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  1
  SUBSTANTIALLY EQUIVALENT 10
ZIMMER, INC.
  3
  SUBSTANTIALLY EQUIVALENT 20

Device Problems
No Information 4020
Dislodged or dislocated 1959
Implant, removal of 1875
No code available 1257
Dislocated 871
Metal shedding debris 740
Naturally worn 704
Loose 410
Unknown (for use when the device problem is not known) 392
Loss of osseointegration 382
Corrosion 346
Noise, Audible 300
Fracture 242
Loss of or failure to bond 235
Break 190
Malposition of device 169
Device remains implanted 164
Explanted 153
Component(s), worn 147
Disassembly 124
Loose or intermittent connection 102
Other (for use when an appropriate device code cannot be identified) 101
Migration of device or device component 86
No Known Device Problem 85
Material integrity issue 63
Failure to Adhere or Bond 47
Slippage of device or device component 45
Detachment of device component 43
Fitting problem 39
Unstable 35
Device operates differently than expected 32
Size incorrect for patient 28
Degraded 28
Mechanical issue 28
Material erosion 23
Difficult to insert 21
Incompatibility problem 21
Tear, rip or hole in device packaging 17
Positioning Issue 16
Component(s), broken 16
Crack 15
Difficult to remove 14
Foreign material present in device 14
Component incompatible 13
Packaging issue 12
Not Applicable 12
Manufacturing or shipping issue associated with device 11
Component missing 11
Malfunction 11
Disengaged 10
Patient-device incompatibility 9
Material deformation 8
Osseointegration issue 8
Foreign material 8
Device, or device fragments remain in patient 7
Device markings issue 6
Device packaging compromised 6
Noise 5
Mislabeled 4
Material discolored 4
Device-device incompatibility 4
Connection issue 3
Detachment of device or device component 3
Incomplete or missing packaging 3
Defective item 3
Failure to separate 3
Unintended movement 3
Displacement 3
Device expiration issue 3
Unsealed device packaging 3
Difficult to position 3
Material separation 3
Defective component 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Failure to osseointegrate 2
Device damaged prior to use 2
Replace 2
User used incorrect product for intended use 2
Product quality issue 2
Dislodged 2
Application interface becomes non-functional or program exits abnormally 2
Component falling 2
Material Protrusion 2
Mechanical jam 2
Item contaminated during manufacturing or shipping 2
Structural problem 2
Failure to disconnect 2
Failure to cut 2
Out-of-box failure 2
Device Issue 2
Device, removal of (non-implant) 2
Component or accessory incompatibility 2
Electrical shorting 2
Extrusion 1
Failure to unwrap 1
Difficult to advance 1
Difficult to open or close 1
Aspiration issue 1
Device disinfection or sterilization issue 1
Total Device Problems 15834

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 1 5 3 2 2 8 4 4 2 4
Class III 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. III Jun-11-2015
2 Biomet, Inc. II Dec-17-2014
3 Biomet, Inc. II Sep-17-2008
4 Biopro, Inc. II Nov-04-2011
5 DePuy Orthopaedics, Inc. II Jun-29-2012
6 Encore Medical, Lp II Jan-11-2012
7 Encore Medical, Lp II Aug-26-2008
8 Encore Medical, Lp II Jul-23-2007
9 Medacta Usa Inc II Nov-08-2012
10 Smith & Nephew Inc II Nov-20-2009
11 Stryker Howmedica Osteonics Corp. II Nov-17-2015
12 Stryker Howmedica Osteonics Corp. II Mar-03-2015
13 Stryker Howmedica Osteonics Corp. II Dec-07-2013
14 Stryker Howmedica Osteonics Corp. II Nov-13-2012
15 Stryker Howmedica Osteonics Corp. II Jul-10-2012
16 Stryker Howmedica Osteonics Corp. II May-13-2010
17 Stryker Howmedica Osteonics Corp. II May-12-2010
18 Stryker Howmedica Osteonics Corp. II Jan-26-2009
19 Stryker Howmedica Osteonics Corp. II Apr-22-2008
20 Stryker Howmedica Osteonics Corp. II Feb-26-2008
21 Stryker Howmedica Osteonics Corp. II Feb-07-2008
22 Zimmer Biomet, Inc. II Feb-22-2016
23 Zimmer Inc. II Jan-25-2012
24 Zimmer Inc. II Sep-27-2011
25 Zimmer Inc. II Jul-23-2009
26 Zimmer Manufacturing B.V. II May-16-2016
27 Zimmer Manufacturing B.V. II Mar-12-2016
28 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
29 Zimmer, Inc. II Oct-20-2014
30 Zimmer, Inc. II Aug-26-2014
31 Zimmer, Inc. II Feb-20-2014
32 Zimmer, Inc. II Dec-30-2013
33 Zimmer, Inc. II Nov-14-2013
34 Zimmer, Inc. II Oct-25-2013
35 Zimmer, Inc. II Nov-06-2012
36 Zimmer, Inc. II Oct-15-2012

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