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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 3
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 10
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
CORIN U.S.A. LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CPM MEDICAL CONSULTANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL, L.P DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 4
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 3
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMA CORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V
  SUBSTANTIALLY EQUIVALENT 3
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
MERIL HEALTHCARE PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEXTSTEP ARTHROPEDIX
  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 4
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
SUZHOU MICROPORT ORTHORECON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TJC LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNIK ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2021 9408 9429
2022 8363 8428
2023 8947 8984
2024 10828 11062
2025 9422 23986

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20662 35283
Naturally Worn 5806 5829
Fracture 4922 10470
Loosening of Implant Not Related to Bone-Ingrowth 4237 13432
Unstable 2344 2346
Loss of or Failure to Bond 2327 2340
Insufficient Information 2024 4819
Appropriate Term/Code Not Available 1447 1448
Detachment of Device or Device Component 1042 1045
Break 1024 1026
Device Appears to Trigger Rejection 702 702
Device Dislodged or Dislocated 684 1345
Migration 606 614
Difficult to Insert 439 440
Mechanical Problem 335 335
Patient Device Interaction Problem 335 336
Osseointegration Problem 288 6025
Noise, Audible 227 232
Tear, Rip or Hole in Device Packaging 219 220
Loose or Intermittent Connection 218 219
Crack 214 217
Patient-Device Incompatibility 213 215
Positioning Failure 181 182
Use of Device Problem 155 156
Inadequacy of Device Shape and/or Size 136 138
Device Contaminated During Manufacture or Shipping 135 137
Material Erosion 127 9383
Malposition of Device 125 8513
Packaging Problem 122 122
Failure to Cut 115 119
Loss of Osseointegration 115 124
No Apparent Adverse Event 111 112
Difficult to Open or Remove Packaging Material 86 86
Improper or Incorrect Procedure or Method 84 5217
Off-Label Use 81 81
Degraded 80 112
Lack of Effect 76 76
Delivered as Unsterile Product 73 73
Material Deformation 70 70
Connection Problem 65 65
Device-Device Incompatibility 63 63
Unintended Movement 58 59
Device Damaged Prior to Use 55 56
Mechanical Jam 55 55
Manufacturing, Packaging or Shipping Problem 54 55
Biocompatibility 53 53
Corroded 50 50
Peeled/Delaminated 38 38
Material Integrity Problem 34 34
Failure to Osseointegrate 34 34

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12227 17892
No Clinical Signs, Symptoms or Conditions 7692 7716
Joint Laxity 6982 16319
Unspecified Infection 6316 15601
Failure of Implant 6297 6336
Insufficient Information 6127 19472
Swelling/ Edema 3929 3953
Osteolysis 3000 8743
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2866 2870
Loss of Range of Motion 2673 3702
Synovitis 2427 7306
Ambulation Difficulties 2418 2435
Implant Pain 1771 1773
Discomfort 1716 1720
Scar Tissue 1107 1109
Fall 1052 1070
Bone Fracture(s) 923 9280
Adhesion(s) 880 883
Muscular Rigidity 740 752
Unspecified Tissue Injury 643 647
Inadequate Osseointegration 582 584
Inflammation 531 533
Joint Dislocation 529 9312
Balance Problems 493 493
Metal Related Pathology 417 5293
Cyst(s) 311 312
Thrombosis/Thrombus 305 1086
Hypersensitivity/Allergic reaction 284 285
Wound Dehiscence 277 300
Emotional Changes 276 276
Bacterial Infection 253 253
Limb Fracture 252 255
Muscle/Tendon Damage 240 240
Fluid Discharge 213 215
Hematoma 212 421
Unspecified Musculoskeletal problem 194 194
Foreign Body Reaction 187 188
Hemorrhage/Bleeding 177 179
Muscle Weakness 152 152
Arthralgia 151 6144
Impaired Healing 151 360
Ossification 134 5008
Post Operative Wound Infection 133 165
Damage to Ligament(s) 127 128
Osteopenia/ Osteoporosis 126 126
Fibrosis 125 126
Joint Contracture 122 122
Necrosis 113 4989
Sepsis 110 111
Pulmonary Embolism 102 102

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