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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 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 5281
Dislodged or dislocated 2355
Implant, removal of 1875
No code available 1775
Dislocated 871
Metal shedding debris 856
Naturally worn 776
Loss of osseointegration 464
Corrosion 454
Loose 410
Unknown (for use when the device problem is not known) 392
Noise, Audible 369
Fracture 307
Loss of or failure to bond 261
Break 225
Malposition of device 225
Device remains implanted 164
Disassembly 156
Migration of device or device component 155
Explanted 153
Component(s), worn 147
No Known Device Problem 114
Loose or intermittent connection 106
Other (for use when an appropriate device code cannot be identified) 101
Material integrity issue 83
Failure to Adhere or Bond 61
Material erosion 59
Detachment of device component 51
Slippage of device or device component 46
Unstable 46
Device operates differently than expected 46
Mechanical issue 43
Fitting problem 40
Degraded 36
Size incorrect for patient 29
Positioning Issue 24
Difficult to insert 24
Incompatibility problem 24
Difficult to remove 22
Tear, rip or hole in device packaging 17
Material deformation 17
Component(s), broken 16
Not Applicable 16
Crack 15
Packaging issue 14
Foreign material present in device 14
Component incompatible 13
Component missing 13
Osseointegration issue 13
Patient-device incompatibility 13
Manufacturing or shipping issue associated with device 12
Malfunction 11
Detachment of device or device component 11
Disengaged 10
Failure to separate 9
Difficult to position 9
Foreign material 8
Device, or device fragments remain in patient 7
Device markings issue 7
Device packaging compromised 7
Component or accessory incompatibility 7
Device-device incompatibility 7
Device damaged prior to use 6
Unintended movement 5
Noise 5
Use of Device Issue 5
Mislabeled 4
Connection issue 4
Material disintegration 4
Material discolored 4
Mechanical jam 4
Material separation 4
Device expiration issue 4
Defective item 3
Displacement 3
Incomplete or missing packaging 3
Unsealed device packaging 3
User used incorrect product for intended use 3
Item contaminated during manufacturing or shipping 3
Improper or incorrect procedure or method 3
Defective component 3
Misconnection 3
Bent 3
Failure to osseointegrate 2
Application interface becomes non-functional or program exits abnormally 2
Product quality issue 2
Replace 2
Difficult to open or close 2
Failure to cut 2
Structural problem 2
Device, removal of (non-implant) 2
Electrical shorting 2
Dislodged 2
Device Issue 2
Material Protrusion 2
Material fragmentation 2
Out-of-box failure 2
Biocompatibility issue 2
Component falling 2
Entrapment of device or device component 2
Total Device Problems 19005

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 2
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 Feb-22-2016
27 Zimmer Inc. II Jan-25-2012
28 Zimmer Inc. II Sep-27-2011
29 Zimmer Inc. II Jul-23-2009
30 Zimmer Manufacturing B.V. II May-16-2016
31 Zimmer Manufacturing B.V. II Mar-12-2016
32 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
33 Zimmer, Inc. II Oct-20-2014
34 Zimmer, Inc. II Aug-26-2014
35 Zimmer, Inc. II Feb-20-2014
36 Zimmer, Inc. II Dec-30-2013
37 Zimmer, Inc. II Nov-14-2013
38 Zimmer, Inc. II Oct-25-2013
39 Zimmer, Inc. II Nov-06-2012
40 Zimmer, Inc. II Oct-15-2012

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