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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 12
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 INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 3
MATORTHO
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
OMNI
  SUBSTANTIALLY EQUIVALENT 1
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 5
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
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
SURGTECH, INC.
  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 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Insufficient Information 14664
Adverse Event Without Identified Device or Use Problem 7194
Fracture 3937
Loss of or Failure to Bond 3544
Break 2723
Migration or Expulsion of Device 1871
Unstable 1601
Appropriate Term/Code Not Available 1414
Naturally Worn 1390
Loose or Intermittent Connection 917
Failure To Adhere Or Bond 863
Component Missing 841
Device Dislodged or Dislocated 723
Noise, Audible 713
Loosening of Implant Not Related to Bone-Ingrowth 658
Loss of Osseointegration 611
Malposition of device 544
Difficult to Insert 503
Disassembly 478
Migration 413
Detachment of Device or device Component 353
Scratched Material 263
Crack 232
Fitting Problem 199
Device Operates Differently Than Expected 199
Material Integrity Problem 198
Material Deformation 197
Unintended Movement 185
Inadequacy of Device Shape and/or Size 173
Device Contamination with Chemical or Other Material 168
Mechanical Problem 168
Packaging Problem 161
Physical Resistance / Sticking 145
Osseointegration Problem 142
Detachment Of Device Component 130
Degraded 116
Patient Device Interaction Problem 114
Device Slipped 102
Material Erosion 101
Use of Device Problem 99
Device Packaging Compromised 86
Tear, Rip or Hole in Device Packaging 85
Material Twisted / Bent 75
Corroded 74
Material Discolored 72
Device-Device Incompatibility 69
No Apparent Adverse Event 68
Difficult To Position 67
Positioning Problem 67
Delivered as Unsterile Product 62
Metal Shedding Debris 58
Mechanical Jam 51
Improper or Incorrect Procedure or Method 51
Patient-Device Incompatibility 50
Connection Problem 48
Manufacturing, Packaging or Shipping Problem 47
Material Separation 45
Defective Device 43
Device Markings / Labelling Problem 38
Positioning Failure 38
Device Damaged Prior to Use 37
Device Contaminated during manufacture or shipping 37
Off-Label Use 34
Peeled / Delaminated 31
Bent 29
Material Fragmentation 29
Difficult to Remove 28
Compatibility Problem 28
Material Disintegration 26
Device Damaged by Another Device 25
Defective Component 24
Residue After Decontamination 23
Unsealed Device Packaging 22
Failure to Align 22
Pitted 22
Device Issue 20
Incorrect Measurement 20
Component Incompatible 20
Screw 20
Misconnection 20
Contamination / decontamination Problem 18
Device Or Device Fragments Location Unknown 17
Deformation Due to Compressive Stress 16
Incorrect Device Or Component Shipped 16
Separation Problem 15
Material Too Rigid or Stiff 14
Misassembled 13
Shipping Damage or Problem 13
Incomplete or Missing Packaging 13
Biocompatibility 12
Difficult to Open or Remove Packaging Material 12
Device Abrasion From Instrument Or Another Object 12
Sticking 11
Delamination 11
Disconnection 10
Material Distortion 10
Pin 10
Dent in Material 10
Failure to Osseointegrate 10
Component or Accessory Incompatibility 10
Total Device Problems 51011

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 Dec-12-2019
13 Conformis, Inc. II Apr-08-2019
14 Conformis, Inc. II Mar-30-2019
15 DePuy Orthopaedics, Inc. II Aug-29-2018
16 DePuy Orthopaedics, Inc. II Apr-30-2018
17 DePuy Orthopaedics, Inc. II Mar-13-2014
18 DePuy Orthopaedics, Inc. II Feb-24-2014
19 Encore Medical, Lp II Aug-31-2018
20 Encore Medical, Lp II Jan-10-2018
21 Encore Medical, Lp II Oct-20-2017
22 Encore Medical, Lp II Jun-30-2017
23 Encore Medical, Lp II Feb-03-2017
24 Encore Medical, Lp II Dec-14-2016
25 Encore Medical, Lp II Dec-06-2016
26 Encore Medical, Lp II Oct-28-2016
27 Exactech, Inc. II Apr-23-2019
28 Exactech, Inc. II Sep-20-2018
29 Exactech, Inc. II Nov-20-2017
30 Exactech, Inc. II Jun-19-2017
31 Exactech, Inc. II Jan-05-2015
32 Materialise N.V. II Mar-17-2015
33 Materialise USA LLC II Jun-09-2016
34 Materialise USA LLC II Nov-21-2014
35 Medacta Usa Inc II Dec-20-2017
36 Medacta Usa Inc II Jun-26-2015
37 Medtronic Sofamor Danek USA Inc II Mar-21-2017
38 Medtronic Sofamor Danek USA Inc II Aug-23-2016
39 Microport Orthopedics INC. II Mar-06-2015
40 OMNIlife science Inc. II Mar-19-2018
41 Ortho Development Corporation II Jun-26-2015
42 Ortho Development Corporation II Aug-17-2014
43 Ortho Development Corporation II May-13-2014
44 Signal Medical Corporation II Oct-22-2014
45 Signature Orthopedics Pty Limited II Feb-14-2019
46 Smith & Nephew, Inc. II Sep-12-2019
47 Smith & Nephew, Inc. II Mar-22-2019
48 Smith & Nephew, Inc. II Oct-01-2018
49 Smith & Nephew, Inc. II Aug-22-2018
50 Smith & Nephew, Inc. II May-22-2018
51 Smith & Nephew, Inc. II Nov-16-2017
52 Smith & Nephew, Inc. II Jun-12-2017
53 Smith & Nephew, Inc. II Apr-21-2016
54 Smith & Nephew, Inc. II Feb-17-2016
55 Smith & Nephew, Inc. II Jan-04-2016
56 Smith & Nephew, Inc. II Dec-12-2014
57 Stanmore Implants Worldwide Ltd. II May-09-2016
58 Stelkast Co II Jan-14-2015
59 Stryker Howmedica Osteonics Corp. II Aug-09-2016
60 Stryker Howmedica Osteonics Corp. II Dec-02-2015
61 Stryker Howmedica Osteonics Corp. II Nov-09-2015
62 Stryker Howmedica Osteonics Corp. II Aug-10-2015
63 Stryker Howmedica Osteonics Corp. II May-19-2015
64 Stryker Howmedica Osteonics Corp. II May-14-2015
65 United Orthopedic Corporation II Mar-19-2018
66 Zimmer Biomet, Inc. II Nov-07-2019
67 Zimmer Biomet, Inc. II Sep-12-2019
68 Zimmer Biomet, Inc. II Apr-04-2019
69 Zimmer Biomet, Inc. II Feb-23-2019
70 Zimmer Biomet, Inc. II Dec-18-2018
71 Zimmer Biomet, Inc. II Nov-21-2018
72 Zimmer Biomet, Inc. II Sep-25-2018
73 Zimmer Biomet, Inc. II Jun-04-2018
74 Zimmer Biomet, Inc. II Jun-01-2018
75 Zimmer Biomet, Inc. II Jun-01-2018
76 Zimmer Biomet, Inc. II May-11-2018
77 Zimmer Biomet, Inc. II Mar-14-2018
78 Zimmer Biomet, Inc. II Feb-21-2018
79 Zimmer Biomet, Inc. II Feb-15-2018
80 Zimmer Biomet, Inc. II May-18-2017
81 Zimmer Biomet, Inc. II Mar-27-2017
82 Zimmer Biomet, Inc. II Feb-16-2017
83 Zimmer Biomet, Inc. II Jan-28-2017
84 Zimmer Biomet, Inc. II Oct-18-2016
85 Zimmer Biomet, Inc. II Oct-03-2016
86 Zimmer Biomet, Inc. II Feb-22-2016
87 Zimmer CAS II Dec-16-2014
88 Zimmer Manufacturing B.V. II Apr-06-2016
89 Zimmer Manufacturing B.V. II Mar-12-2016
90 Zimmer Manufacturing B.V. II Jan-05-2016
91 Zimmer Manufacturing B.V. II Dec-18-2015
92 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
93 Zimmer, Inc. II Jul-01-2015
94 Zimmer, Inc. II May-01-2015
95 Zimmer, Inc. II Apr-01-2015
96 Zimmer, Inc. II Feb-03-2015
97 Zimmer, Inc. II Dec-23-2014
98 Zimmer, Inc. II Nov-08-2014
99 Zimmer, Inc. II Oct-23-2014
100 Zimmer, Inc. II Sep-04-2014
101 Zimmer, Inc. II Sep-04-2014
102 Zimmer, Inc. II Aug-26-2014
103 Zimmer, Inc. II Aug-21-2014
104 Zimmer, Inc. II Jun-27-2014
105 Zimmer, Inc. II Mar-20-2014
106 Zimmer, Inc. II Feb-20-2014

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