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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 IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 7
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
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 6
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
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 4
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
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 7
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Insufficient Information 14338
Adverse Event Without Identified Device or Use Problem 8120
Fracture 3993
Loss of or Failure to Bond 3747
Break 2739
Migration or Expulsion of Device 1854
Unstable 1588
Naturally Worn 1467
Appropriate Term/Code Not Available 1397
Loose or Intermittent Connection 908
Component Missing 827
Device Dislodged or Dislocated 750
Noise, Audible 736
Loosening of Implant Not Related to Bone-Ingrowth 715
Failure To Adhere Or Bond 699
Loss of Osseointegration 620
Malposition of device 563
Disassembly 465
Difficult to Insert 442
Migration 438
Detachment of Device or device Component 388
Scratched Material 278
Crack 227
Unintended Movement 223
Material Deformation 202
Device Operates Differently Than Expected 196
Fitting Problem 185
Inadequacy of Device Shape and/or Size 177
Device Contamination with Chemical or Other Material 167
Mechanical Problem 162
Patient Device Interaction Problem 159
Packaging Problem 156
Material Integrity Problem 152
Physical Resistance / Sticking 150
Osseointegration Problem 149
Use of Device Problem 118
Degraded 113
Detachment Of Device Component 106
Material Erosion 102
Device-Device Incompatibility 98
Device Slipped 91
Material Twisted / Bent 82
Tear, Rip or Hole in Device Packaging 81
Device Packaging Compromised 79
Corroded 74
Material Discolored 72
Difficult To Position 67
No Apparent Adverse Event 66
Positioning Problem 63
Delivered as Unsterile Product 62
Metal Shedding Debris 57
Connection Problem 51
Patient-Device Incompatibility 51
Mechanical Jam 49
Improper or Incorrect Procedure or Method 47
Material Separation 44
Defective Device 42
Positioning Failure 41
Device Contaminated during manufacture or shipping 39
Device Markings / Labelling Problem 38
Device Damaged Prior to Use 38
Material Disintegration 36
Manufacturing, Packaging or Shipping Problem 34
Peeled / Delaminated 31
Off-Label Use 30
Bent 29
Material Fragmentation 27
Difficult to Remove 27
Device Damaged by Another Device 25
Defective Component 24
Failure to Align 23
Residue After Decontamination 23
Compatibility Problem 22
Incorrect Measurement 22
Unsealed Device Packaging 21
Pitted 20
Misconnection 20
Device Issue 19
Component Incompatible 18
Screw 17
Contamination / decontamination Problem 17
Device Or Device Fragments Location Unknown 16
Deformation Due to Compressive Stress 16
Incorrect Device Or Component Shipped 15
Separation Problem 15
Shipping Damage or Problem 13
Biocompatibility 12
Material Too Rigid or Stiff 12
Misassembled 12
Device Abrasion From Instrument Or Another Object 11
Delamination 11
Difficult to Open or Remove Packaging Material 11
Disconnection 10
Incomplete or Missing Packaging 10
Dent in Material 10
Failure to Osseointegrate 10
Component or Accessory Incompatibility 10
Collapse 9
Product Quality Problem 8
Out-Of-Box Failure 7
Total Device Problems 51851

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

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