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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Product CodeJWH
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 11
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 7
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 3
MATORTHO
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 5
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 14
STELKAST
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Insufficient Information 13592
Adverse Event Without Identified Device or Use Problem 4496
Fracture 3452
Loss of or Failure to Bond 2557
Break 2381
Migration or Expulsion of Device 1860
Unstable 1414
Appropriate Term/Code Not Available 1368
Naturally Worn 1172
Failure To Adhere Or Bond 863
Loose or Intermittent Connection 861
Component Missing 680
Device Dislodged or Dislocated 586
Noise, Audible 576
Loss of Osseointegration 545
Disassembly 478
Difficult to Insert 431
Malposition of device 414
Loosening of Implant Not Related to Bone-Ingrowth 351
Migration 273
Device Operates Differently Than Expected 199
Material Integrity Problem 195
Crack 193
Fitting Problem 184
Detachment of Device or device Component 169
Device Contamination with Chemical or Other Material 165
Scratched Material 164
Mechanical Problem 161
Inadequacy of Device Shape and/or Size 155
Material Deformation 144
Packaging Problem 136
Unintended Movement 134
Osseointegration Problem 132
Detachment Of Device Component 130
Degraded 108
Device Slipped 102
Device Packaging Compromised 86
Material Erosion 84
Tear, Rip or Hole in Device Packaging 72
Patient Device Interaction Problem 71
Physical Resistance / Sticking 71
Difficult To Position 67
Material Discolored 67
Use of Device Problem 67
No Apparent Adverse Event 66
Positioning Problem 63
Metal Shedding Debris 58
Delivered as Unsterile Product 52
Improper or Incorrect Procedure or Method 49
Mechanical Jam 49
Device-Device Incompatibility 42
Connection Problem 41
Manufacturing, Packaging or Shipping Problem 40
Defective Device 37
Corroded 37
Material Twisted / Bent 36
Patient-Device Incompatibility 35
Device Markings / Labelling Problem 35
Device Contaminated during manufacture or shipping 34
Off-Label Use 33
Material Separation 32
Peeled / Delaminated 29
Device Damaged Prior to Use 29
Bent 29
Difficult to Remove 28
Material Fragmentation 28
Device Damaged by Another Device 24
Compatibility Problem 24
Defective Component 23
Material Disintegration 23
Residue After Decontamination 23
Failure to Align 22
Device Issue 20
Component Incompatible 20
Screw 20
Incorrect Measurement 20
Pitted 20
Misconnection 20
Unsealed Device Packaging 19
Device Or Device Fragments Location Unknown 17
Incorrect Device Or Component Shipped 16
Deformation Due to Compressive Stress 16
Separation Problem 14
Shipping Damage or Problem 13
Misassembled 13
Device Abrasion From Instrument Or Another Object 12
Biocompatibility 12
Material Too Rigid or Stiff 12
Incomplete or Missing Packaging 12
Sticking 11
Delamination 11
Contamination / decontamination Problem 11
Pin 10
Disconnection 10
Material Distortion 10
Difficult to Open or Remove Packaging Material 10
Collapse 9
Failure to Osseointegrate 9
Device Operational Issue 7
Component Falling 7
Total Device Problems 42808

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems II Jun-26-2015
2 Aesculap, Inc. II Mar-03-2016
3 Arthrex, Inc. II Mar-19-2016
4 Biomet, Inc. III Jun-11-2015
5 Biomet, Inc. II Aug-15-2014
6 ConforMIS, Inc. II Oct-02-2018
7 ConforMIS, Inc. II Feb-13-2018
8 ConforMIS, Inc. II Jan-10-2017
9 ConforMIS, Inc. II Nov-25-2016
10 ConforMIS, Inc. II Oct-21-2015
11 ConforMIS, Inc. II Dec-11-2014
12 Conformis, Inc. II Apr-08-2019
13 Conformis, Inc. II Mar-30-2019
14 DePuy Orthopaedics, Inc. II Aug-29-2018
15 DePuy Orthopaedics, Inc. II Apr-30-2018
16 DePuy Orthopaedics, Inc. II Mar-13-2014
17 DePuy Orthopaedics, Inc. II Feb-24-2014
18 Encore Medical, Lp II Aug-31-2018
19 Encore Medical, Lp II Jan-10-2018
20 Encore Medical, Lp II Oct-20-2017
21 Encore Medical, Lp II Jun-30-2017
22 Encore Medical, Lp II Feb-03-2017
23 Encore Medical, Lp II Dec-14-2016
24 Encore Medical, Lp II Dec-06-2016
25 Encore Medical, Lp II Oct-28-2016
26 Exactech, Inc. II Apr-23-2019
27 Exactech, Inc. II Sep-20-2018
28 Exactech, Inc. II Nov-20-2017
29 Exactech, Inc. II Jun-19-2017
30 Exactech, Inc. II Jan-05-2015
31 Materialise N.V. II Mar-17-2015
32 Materialise USA LLC II Jun-09-2016
33 Materialise USA LLC II Nov-21-2014
34 Medacta Usa Inc II Dec-20-2017
35 Medacta Usa Inc II Jun-26-2015
36 Medtronic Sofamor Danek USA Inc II Mar-21-2017
37 Medtronic Sofamor Danek USA Inc II Aug-23-2016
38 Microport Orthopedics INC. II Mar-06-2015
39 OMNIlife science Inc. II Mar-19-2018
40 Ortho Development Corporation II Jun-26-2015
41 Ortho Development Corporation II Aug-17-2014
42 Ortho Development Corporation II May-13-2014
43 Signal Medical Corporation II Oct-22-2014
44 Signature Orthopedics Pty Limited II Feb-14-2019
45 Smith & Nephew, Inc. II Mar-22-2019
46 Smith & Nephew, Inc. II Oct-01-2018
47 Smith & Nephew, Inc. II Aug-22-2018
48 Smith & Nephew, Inc. II May-22-2018
49 Smith & Nephew, Inc. II Nov-16-2017
50 Smith & Nephew, Inc. II Jun-12-2017
51 Smith & Nephew, Inc. II Apr-21-2016
52 Smith & Nephew, Inc. II Feb-17-2016
53 Smith & Nephew, Inc. II Jan-04-2016
54 Smith & Nephew, Inc. II Dec-12-2014
55 Stanmore Implants Worldwide Ltd. II May-09-2016
56 Stelkast Co II Jan-14-2015
57 Stryker Howmedica Osteonics Corp. II Aug-09-2016
58 Stryker Howmedica Osteonics Corp. II Dec-02-2015
59 Stryker Howmedica Osteonics Corp. II Nov-09-2015
60 Stryker Howmedica Osteonics Corp. II Aug-10-2015
61 Stryker Howmedica Osteonics Corp. II May-19-2015
62 Stryker Howmedica Osteonics Corp. II May-14-2015
63 United Orthopedic Corporation II Mar-19-2018
64 Zimmer Biomet, Inc. II Apr-04-2019
65 Zimmer Biomet, Inc. II Feb-23-2019
66 Zimmer Biomet, Inc. II Dec-18-2018
67 Zimmer Biomet, Inc. II Nov-21-2018
68 Zimmer Biomet, Inc. II Sep-25-2018
69 Zimmer Biomet, Inc. II Jun-04-2018
70 Zimmer Biomet, Inc. II Jun-01-2018
71 Zimmer Biomet, Inc. II Jun-01-2018
72 Zimmer Biomet, Inc. II May-11-2018
73 Zimmer Biomet, Inc. II Mar-14-2018
74 Zimmer Biomet, Inc. II Feb-21-2018
75 Zimmer Biomet, Inc. II Feb-15-2018
76 Zimmer Biomet, Inc. II May-18-2017
77 Zimmer Biomet, Inc. II Mar-27-2017
78 Zimmer Biomet, Inc. II Feb-16-2017
79 Zimmer Biomet, Inc. II Jan-28-2017
80 Zimmer Biomet, Inc. II Oct-18-2016
81 Zimmer Biomet, Inc. II Oct-03-2016
82 Zimmer Biomet, Inc. II Feb-22-2016
83 Zimmer CAS II Dec-16-2014
84 Zimmer Manufacturing B.V. II Apr-06-2016
85 Zimmer Manufacturing B.V. II Mar-12-2016
86 Zimmer Manufacturing B.V. II Jan-05-2016
87 Zimmer Manufacturing B.V. II Dec-18-2015
88 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
89 Zimmer, Inc. II Jul-01-2015
90 Zimmer, Inc. II May-01-2015
91 Zimmer, Inc. II Apr-01-2015
92 Zimmer, Inc. II Feb-03-2015
93 Zimmer, Inc. II Dec-23-2014
94 Zimmer, Inc. II Nov-08-2014
95 Zimmer, Inc. II Oct-23-2014
96 Zimmer, Inc. II Sep-04-2014
97 Zimmer, Inc. II Sep-04-2014
98 Zimmer, Inc. II Aug-26-2014
99 Zimmer, Inc. II Aug-21-2014
100 Zimmer, Inc. II Jun-27-2014
101 Zimmer, Inc. II Mar-20-2014
102 Zimmer, Inc. II Feb-20-2014

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