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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 2
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 1
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
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 5

MDR Year MDR Reports MDR Events
2020 12591 12591
2021 9407 9407
2022 8361 8361
2023 8980 8986
2024 10861 11094
2025 976 989

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21602 21764
Fracture 5362 5362
Naturally Worn 5242 5264
Loosening of Implant Not Related to Bone-Ingrowth 4079 4115
Loss of or Failure to Bond 2846 2846
Insufficient Information 2654 2654
Unstable 2082 2082
Appropriate Term/Code Not Available 1899 1899
Break 1687 1687
Detachment of Device or Device Component 1133 1133
Device Dislodged or Dislocated 747 747
Migration 716 716
Device Appears to Trigger Rejection 496 496
Patient Device Interaction Problem 468 468
Difficult to Insert 434 434
Loose or Intermittent Connection 395 395
Noise, Audible 337 337
Crack 313 313
Mechanical Problem 270 270
Tear, Rip or Hole in Device Packaging 232 232
Use of Device Problem 225 225
Osseointegration Problem 219 219
Inadequacy of Device Shape and/or Size 209 209
Malposition of Device 203 203
Loss of Osseointegration 192 192
Positioning Failure 172 172
Device Contaminated During Manufacture or Shipping 152 152
Patient-Device Incompatibility 136 136
Unintended Movement 132 132
Packaging Problem 125 125
Material Erosion 118 118
Failure to Cut 115 115
Connection Problem 113 113
Material Deformation 109 109
No Apparent Adverse Event 105 105
Off-Label Use 91 91
Physical Resistance/Sticking 82 82
Difficult to Open or Remove Packaging Material 81 81
Corroded 81 81
Material Twisted/Bent 80 80
Improper or Incorrect Procedure or Method 75 75
Device-Device Incompatibility 74 74
Degraded 70 102
Fitting Problem 68 68
Scratched Material 67 67
Manufacturing, Packaging or Shipping Problem 61 61
Mechanical Jam 59 59
Delivered as Unsterile Product 59 59
Defective Device 57 57
Material Integrity Problem 52 52

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12660 12714
No Clinical Signs, Symptoms or Conditions 7213 7235
Unspecified Infection 6977 6983
Failure of Implant 6533 6533
Joint Laxity 5478 5478
Insufficient Information 4917 5074
No Code Available 4709 4709
Swelling/ Edema 3275 3281
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2636 2636
Osteolysis 2427 2427
Loss of Range of Motion 2424 2472
Ambulation Difficulties 2018 2020
Synovitis 1920 1920
Implant Pain 1445 1445
Discomfort 1377 1377
Adhesion(s) 1294 1294
Bone Fracture(s) 1103 1120
Injury 1095 1095
Fall 1067 1067
Muscular Rigidity 916 916
Scar Tissue 909 909
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 559 560
Unspecified Tissue Injury 550 550
Inflammation 533 533
Inadequate Osseointegration 522 522
Limited Mobility Of The Implanted Joint 515 515
Edema 384 384
Balance Problems 372 372
Wound Dehiscence 344 344
Bacterial Infection 322 322
Metal Related Pathology 318 318
Hypersensitivity/Allergic reaction 298 298
Swelling 296 296
Thrombosis/Thrombus 280 280
Hematoma 265 265
Hemorrhage/Bleeding 255 255
Cyst(s) 229 229
Emotional Changes 222 222
Muscle/Tendon Damage 215 215
Foreign Body Reaction 211 211
Impaired Healing 208 208
Limb Fracture 195 195
Fluid Discharge 187 187
Joint Disorder 172 172
Unspecified Musculoskeletal problem 157 157
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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