• 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, 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 9
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 6450
Dislodged or dislocated 2644
No code available 1981
Implant, removal of 1875
Metal shedding debris 913
Dislocated 871
Naturally worn 826
Corrosion 577
Loss of osseointegration 511
Loose 410
Noise, Audible 398
Unknown (for use when the device problem is not known) 392
Fracture 342
Loss of or failure to bond 271
Malposition of device 256
Break 234
Migration of device or device component 213
Disassembly 169
Device remains implanted 164
Explanted 153
No Known Device Problem 152
Component(s), worn 147
Loose or intermittent connection 111
Other (for use when an appropriate device code cannot be identified) 101
Material integrity issue 89
Material erosion 81
Mechanical issue 67
Failure to Adhere or Bond 66
Unstable 58
Detachment of device component 55
Degraded 42
Fitting problem 41
Slippage of device or device component 40
Difficult to insert 39
Device operates differently than expected 37
Positioning Issue 29
Size incorrect for patient 29
Incompatibility problem 28
Difficult to remove 22
Material deformation 21
Tear, rip or hole in device packaging 18
Foreign material present in device 17
Packaging issue 17
Detachment of device or device component 16
Component(s), broken 16
Component incompatible 15
Crack 14
Manufacturing or shipping issue associated with device 14
Osseointegration issue 13
Component missing 13
Difficult to position 13
Failure to separate 12
Device packaging compromised 12
Patient-device incompatibility 12
Malfunction 11
Not Applicable 11
Disengaged 10
Foreign material 8
Failure to osseointegrate 8
Device markings issue 8
Device-device incompatibility 8
Component or accessory incompatibility 7
Device, or device fragments remain in patient 7
Bent 6
Mechanical jam 6
Item contaminated during manufacturing or shipping 5
Device damaged prior to use 5
Material disintegration 5
Material discolored 5
Noise 5
Use of Device Issue 4
Mislabeled 4
Device expiration issue 4
Connection issue 4
Defective component 3
Incomplete or missing packaging 3
Material Protrusion 3
Unintended movement 3
Displacement 3
Entrapment of device or device component 3
Material fragmentation 3
Component falling 3
Misconnection 3
Unsealed device packaging 3
Material separation 3
Shelf life exceeded 2
Improper or incorrect procedure or method 2
User used incorrect product for intended use 2
Replace 2
Delivered as unsterile product 2
Blockage within device or device component 2
Application interface becomes non-functional or program exits abnormally 2
Dislodged 2
Scratched material 2
Device or device component damaged by another device 2
Electrical shorting 2
Device Issue 2
Structural problem 2
Failure to disconnect 2
Biocompatibility issue 2
Total Device Problems 21301

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 1 5 3 2 2 8 4 4 2 6 3
Class III 0 0 0 0 0 0 0 0 1 0 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 Exactech, Inc. II Jan-17-2017
10 Medacta Usa Inc II Nov-08-2012
11 Smith & Nephew Inc II Nov-20-2009
12 Smith & Nephew, Inc. II Jan-11-2017
13 Stryker Howmedica Osteonics Corp. II Nov-09-2016
14 Stryker Howmedica Osteonics Corp. II Aug-11-2016
15 Stryker Howmedica Osteonics Corp. II Nov-17-2015
16 Stryker Howmedica Osteonics Corp. II Mar-03-2015
17 Stryker Howmedica Osteonics Corp. II Dec-07-2013
18 Stryker Howmedica Osteonics Corp. II Nov-13-2012
19 Stryker Howmedica Osteonics Corp. II Jul-10-2012
20 Stryker Howmedica Osteonics Corp. II May-13-2010
21 Stryker Howmedica Osteonics Corp. II May-12-2010
22 Stryker Howmedica Osteonics Corp. II Jan-26-2009
23 Stryker Howmedica Osteonics Corp. II Apr-22-2008
24 Stryker Howmedica Osteonics Corp. II Feb-26-2008
25 Stryker Howmedica Osteonics Corp. II Feb-07-2008
26 Zimmer Biomet, Inc. II Mar-27-2017
27 Zimmer Biomet, Inc. II Feb-22-2016
28 Zimmer Inc. II Jan-25-2012
29 Zimmer Inc. II Sep-27-2011
30 Zimmer Inc. II Jul-23-2009
31 Zimmer Manufacturing B.V. II May-16-2016
32 Zimmer Manufacturing B.V. II Mar-12-2016
33 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
34 Zimmer, Inc. II Oct-20-2014
35 Zimmer, Inc. II Aug-26-2014
36 Zimmer, Inc. II Feb-20-2014
37 Zimmer, Inc. II Dec-30-2013
38 Zimmer, Inc. II Nov-14-2013
39 Zimmer, Inc. II Oct-25-2013
40 Zimmer, Inc. II Nov-06-2012
41 Zimmer, Inc. II Oct-15-2012

-
-