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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 4271
Dislodged or dislocated 2084
Implant, removal of 1875
No code available 1352
Dislocated 871
Metal shedding debris 761
Naturally worn 721
Loose 410
Loss of osseointegration 402
Unknown (for use when the device problem is not known) 392
Corrosion 365
Noise, Audible 313
Fracture 257
Loss of or failure to bond 241
Break 200
Malposition of device 183
Device remains implanted 164
Explanted 153
Component(s), worn 147
Disassembly 133
Loose or intermittent connection 105
Other (for use when an appropriate device code cannot be identified) 101
Migration of device or device component 97
No Known Device Problem 88
Material integrity issue 69
Failure to Adhere or Bond 47
Detachment of device component 46
Slippage of device or device component 45
Unstable 39
Fitting problem 39
Mechanical issue 34
Device operates differently than expected 32
Degraded 30
Material erosion 29
Size incorrect for patient 28
Incompatibility problem 24
Difficult to insert 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
Not Applicable 13
Component incompatible 13
Packaging issue 12
Manufacturing or shipping issue associated with device 12
Component missing 12
Malfunction 11
Patient-device incompatibility 11
Material deformation 10
Osseointegration issue 10
Disengaged 10
Foreign material 8
Device, or device fragments remain in patient 7
Device packaging compromised 7
Device-device incompatibility 6
Device markings issue 6
Detachment of device or device component 6
Failure to separate 5
Noise 5
Use of Device Issue 4
Mislabeled 4
Material discolored 4
Component or accessory incompatibility 4
Connection issue 3
Defective item 3
Defective component 3
Incomplete or missing packaging 3
Unintended movement 3
Displacement 3
Device expiration issue 3
Unsealed device packaging 3
Difficult to position 3
User used incorrect product for intended use 3
Material separation 3
Misconnection 3
Improper or incorrect procedure or method 3
Device damaged prior to use 2
Failure to osseointegrate 2
Replace 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
Electrical shorting 2
Device Issue 2
Out-of-box failure 2
Structural problem 2
Failure to disconnect 2
Failure to cut 2
Device, removal of (non-implant) 2
Aspiration issue 1
Device disinfection or sterilization issue 1
Device misassembled during manufacturing or shipping 1
Device or device component damaged by another device 1
Difficult to advance 1
Total Device Problems 16519

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 5
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 Aug-11-2016
12 Stryker Howmedica Osteonics Corp. II Nov-17-2015
13 Stryker Howmedica Osteonics Corp. II Mar-03-2015
14 Stryker Howmedica Osteonics Corp. II Dec-07-2013
15 Stryker Howmedica Osteonics Corp. II Nov-13-2012
16 Stryker Howmedica Osteonics Corp. II Jul-10-2012
17 Stryker Howmedica Osteonics Corp. II May-13-2010
18 Stryker Howmedica Osteonics Corp. II May-12-2010
19 Stryker Howmedica Osteonics Corp. II Jan-26-2009
20 Stryker Howmedica Osteonics Corp. II Apr-22-2008
21 Stryker Howmedica Osteonics Corp. II Feb-26-2008
22 Stryker Howmedica Osteonics Corp. II Feb-07-2008
23 Zimmer Biomet, Inc. II Feb-22-2016
24 Zimmer Inc. II Jan-25-2012
25 Zimmer Inc. II Sep-27-2011
26 Zimmer Inc. II Jul-23-2009
27 Zimmer Manufacturing B.V. II May-16-2016
28 Zimmer Manufacturing B.V. II Mar-12-2016
29 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
30 Zimmer, Inc. II Oct-20-2014
31 Zimmer, Inc. II Aug-26-2014
32 Zimmer, Inc. II Feb-20-2014
33 Zimmer, Inc. II Dec-30-2013
34 Zimmer, Inc. II Nov-14-2013
35 Zimmer, Inc. II Oct-25-2013
36 Zimmer, Inc. II Nov-06-2012
37 Zimmer, Inc. II Oct-15-2012

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