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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 4966
Dislodged or dislocated 2254
Implant, removal of 1875
No code available 1672
Dislocated 871
Metal shedding debris 842
Naturally worn 753
Loss of osseointegration 451
Corrosion 431
Loose 410
Unknown (for use when the device problem is not known) 392
Noise, Audible 354
Fracture 287
Loss of or failure to bond 255
Break 216
Malposition of device 212
Device remains implanted 164
Explanted 153
Disassembly 148
Component(s), worn 147
Migration of device or device component 138
Loose or intermittent connection 106
No Known Device Problem 105
Other (for use when an appropriate device code cannot be identified) 101
Material integrity issue 80
Detachment of device component 48
Failure to Adhere or Bond 48
Material erosion 48
Slippage of device or device component 46
Unstable 44
Device operates differently than expected 41
Fitting problem 40
Mechanical issue 40
Degraded 34
Size incorrect for patient 29
Incompatibility problem 24
Difficult to insert 23
Difficult to remove 21
Positioning Issue 21
Tear, rip or hole in device packaging 17
Material deformation 16
Not Applicable 16
Component(s), broken 16
Crack 15
Foreign material present in device 14
Osseointegration issue 13
Packaging issue 13
Component incompatible 13
Manufacturing or shipping issue associated with device 12
Component missing 12
Patient-device incompatibility 12
Malfunction 11
Disengaged 10
Foreign material 8
Failure to separate 8
Device packaging compromised 7
Device, or device fragments remain in patient 7
Device-device incompatibility 6
Detachment of device or device component 6
Device markings issue 6
Component or accessory incompatibility 6
Unintended movement 5
Noise 5
Use of Device Issue 5
Material separation 4
Difficult to position 4
Mislabeled 4
Material discolored 4
Mechanical jam 4
Connection issue 4
Defective item 3
Defective component 3
Incomplete or missing packaging 3
Item contaminated during manufacturing or shipping 3
Bent 3
Displacement 3
Device expiration issue 3
Unsealed device packaging 3
Misconnection 3
User used incorrect product for intended use 3
Improper or incorrect procedure or method 3
Device damaged prior to use 2
Failure to osseointegrate 2
Product quality issue 2
Replace 2
Dislodged 2
Material fragmentation 2
Component falling 2
Material disintegration 2
Application interface becomes non-functional or program exits abnormally 2
Electrical shorting 2
Difficult to open or close 2
Material Protrusion 2
Device Issue 2
Out-of-box failure 2
Failure to cut 2
Structural problem 2
Failure to disconnect 2
Device, removal of (non-implant) 2
Biocompatibility issue 2
Total Device Problems 18244

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 6
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-09-2016
12 Stryker Howmedica Osteonics Corp. II Aug-11-2016
13 Stryker Howmedica Osteonics Corp. II Nov-17-2015
14 Stryker Howmedica Osteonics Corp. II Mar-03-2015
15 Stryker Howmedica Osteonics Corp. II Dec-07-2013
16 Stryker Howmedica Osteonics Corp. II Nov-13-2012
17 Stryker Howmedica Osteonics Corp. II Jul-10-2012
18 Stryker Howmedica Osteonics Corp. II May-13-2010
19 Stryker Howmedica Osteonics Corp. II May-12-2010
20 Stryker Howmedica Osteonics Corp. II Jan-26-2009
21 Stryker Howmedica Osteonics Corp. II Apr-22-2008
22 Stryker Howmedica Osteonics Corp. II Feb-26-2008
23 Stryker Howmedica Osteonics Corp. II Feb-07-2008
24 Zimmer Biomet, Inc. II Feb-22-2016
25 Zimmer Inc. II Jan-25-2012
26 Zimmer Inc. II Sep-27-2011
27 Zimmer Inc. II Jul-23-2009
28 Zimmer Manufacturing B.V. II May-16-2016
29 Zimmer Manufacturing B.V. II Mar-12-2016
30 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
31 Zimmer, Inc. II Oct-20-2014
32 Zimmer, Inc. II Aug-26-2014
33 Zimmer, Inc. II Feb-20-2014
34 Zimmer, Inc. II Dec-30-2013
35 Zimmer, Inc. II Nov-14-2013
36 Zimmer, Inc. II Oct-25-2013
37 Zimmer, Inc. II Nov-06-2012
38 Zimmer, Inc. II Oct-15-2012

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