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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
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 4
BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIORAD MEDISYS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 8
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 5
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CPM MEDICAL CONSULTANTS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 4
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P. (DBA ENOVIS)
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P. DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 4
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 4
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
SHALBY ADVANCED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MICROPORT ORTHORECON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TJC LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNIK ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2020 12591 12591
2021 9407 9407
2022 8361 8361
2023 8980 8986
2024 10859 11092
2025 1871 1884

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21951 22113
Fracture 5444 5444
Naturally Worn 5431 5453
Loosening of Implant Not Related to Bone-Ingrowth 4227 4263
Loss of or Failure to Bond 2867 2867
Insufficient Information 2760 2760
Unstable 2223 2223
Appropriate Term/Code Not Available 1909 1909
Break 1689 1689
Detachment of Device or Device Component 1163 1163
Device Dislodged or Dislocated 762 762
Migration 724 724
Device Appears to Trigger Rejection 515 515
Patient Device Interaction Problem 470 470
Difficult to Insert 436 436
Loose or Intermittent Connection 395 395
Noise, Audible 341 341
Crack 315 315
Mechanical Problem 289 289
Tear, Rip or Hole in Device Packaging 235 235
Use of Device Problem 225 225
Osseointegration Problem 224 224
Inadequacy of Device Shape and/or Size 209 209
Malposition of Device 206 206
Loss of Osseointegration 193 193
Positioning Failure 175 175
Device Contaminated During Manufacture or Shipping 155 155
Patient-Device Incompatibility 139 139
Unintended Movement 132 132
Packaging Problem 127 127
Material Erosion 122 122
Failure to Cut 115 115
Connection Problem 113 113
Material Deformation 110 110
No Apparent Adverse Event 105 105
Off-Label Use 91 91
Difficult to Open or Remove Packaging Material 83 83
Physical Resistance/Sticking 82 82
Corroded 81 81
Material Twisted/Bent 80 80
Improper or Incorrect Procedure or Method 76 76
Device-Device Incompatibility 74 74
Degraded 71 103
Fitting Problem 68 68
Scratched Material 67 67
Manufacturing, Packaging or Shipping Problem 63 63
Delivered as Unsterile Product 61 61
Mechanical Jam 61 61
Defective Device 57 57
Device Damaged Prior to Use 53 53

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 13051 13105
No Clinical Signs, Symptoms or Conditions 7293 7315
Unspecified Infection 7087 7093
Failure of Implant 6651 6651
Joint Laxity 5718 5718
Insufficient Information 5064 5221
No Code Available 4709 4709
Swelling/ Edema 3457 3463
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2767 2767
Osteolysis 2641 2641
Loss of Range of Motion 2478 2526
Ambulation Difficulties 2184 2186
Synovitis 2125 2125
Implant Pain 1553 1553
Discomfort 1506 1506
Adhesion(s) 1299 1299
Bone Fracture(s) 1136 1153
Injury 1095 1095
Fall 1079 1079
Scar Tissue 1005 1005
Muscular Rigidity 921 921
No Known Impact Or Consequence To Patient 871 871
No Consequences Or Impact To Patient 716 716
No Patient Involvement 714 714
No Information 589 589
Joint Dislocation 568 569
Unspecified Tissue Injury 560 560
Inflammation 552 552
Inadequate Osseointegration 538 538
Limited Mobility Of The Implanted Joint 515 515
Balance Problems 423 423
Edema 384 384
Wound Dehiscence 348 348
Metal Related Pathology 340 340
Bacterial Infection 323 323
Hypersensitivity/Allergic reaction 301 301
Swelling 296 296
Thrombosis/Thrombus 282 282
Hematoma 268 268
Hemorrhage/Bleeding 256 256
Cyst(s) 256 256
Emotional Changes 238 238
Muscle/Tendon Damage 223 223
Foreign Body Reaction 214 214
Impaired Healing 208 208
Limb Fracture 196 196
Fluid Discharge 187 187
Joint Disorder 172 172
Unspecified Musculoskeletal problem 158 158
Pulmonary Embolism 149 149

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-13-2020
2 Biomet, Inc. II Jan-30-2023
3 Biomet, Inc. II Dec-23-2020
4 Biomet, Inc. II May-28-2020
5 Biomet, Inc. II Apr-03-2020
6 CORENTEC CO., LTD II May-31-2024
7 Conformis, Inc. II Apr-17-2024
8 Conformis, Inc. II Apr-08-2022
9 Conformis, Inc. II Aug-22-2020
10 Conformis, Inc. II Apr-01-2020
11 Corin Ltd II Nov-02-2023
12 Corin Ltd II Nov-21-2022
13 DePuy Orthopaedics, Inc. II Feb-09-2022
14 DePuy Orthopaedics, Inc. II Oct-07-2021
15 DePuy Orthopaedics, Inc. II Aug-25-2021
16 DePuy Orthopaedics, Inc. II Mar-29-2021
17 DePuy Orthopaedics, Inc. II Feb-09-2021
18 Encore Medical, LP II Dec-26-2024
19 Encore Medical, LP II Dec-23-2024
20 Encore Medical, LP II Oct-12-2023
21 Encore Medical, LP II Sep-19-2023
22 Encore Medical, LP II Feb-27-2023
23 Encore Medical, LP II Jun-09-2022
24 Encore Medical, LP II Jul-20-2021
25 Encore Medical, LP II Apr-30-2021
26 Exactech, Inc. II Jun-18-2024
27 Exactech, Inc. II Jan-18-2024
28 Exactech, Inc. II Oct-04-2021
29 Exactech, Inc. II Feb-26-2020
30 Howmedica Osteonics Corp. II Oct-07-2024
31 Howmedica Osteonics Corp. II Jan-31-2024
32 Howmedica Osteonics Corp. II Jun-03-2022
33 Howmedica Osteonics Corp. II Aug-19-2021
34 Howmedica Osteonics Corp. II Apr-09-2021
35 Limacorporate S.p.A II Dec-09-2023
36 Linkbio Corp. II Jun-01-2023
37 Materialise N.V. II Jul-20-2023
38 Ortho Development Corporation II May-06-2020
39 Smith & Nephew Inc II Oct-31-2024
40 Smith & Nephew Inc II Oct-30-2024
41 Smith & Nephew Inc II Sep-20-2023
42 Smith & Nephew Inc II May-16-2022
43 Smith & Nephew, Inc. II Oct-24-2023
44 Smith & Nephew, Inc. II Jul-20-2022
45 Smith & Nephew, Inc. II Jun-24-2021
46 Smith & Nephew, Inc. II Oct-16-2020
47 Smith & Nephew, Inc. II Aug-08-2020
48 Smith & Nephew, Inc. II Mar-17-2020
49 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-18-2024
50 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-03-2023
51 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
52 Zimmer, Inc. II Jan-28-2025
53 Zimmer, Inc. II Apr-22-2024
54 Zimmer, Inc. II Jul-05-2023
55 Zimmer, Inc. II Dec-09-2022
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