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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.
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL, L.P DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 2
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 NV
  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
NOVOSOURCE
  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 9409 9430
2022 8364 8429
2023 8947 8984
2024 10828 11062
2025 9427 31510
2026 2533 2534

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 22023 44163
Naturally Worn 5992 6015
Fracture 5113 15914
Loosening of Implant Not Related to Bone-Ingrowth 4441 21155
Unstable 2512 2514
Loss of or Failure to Bond 2465 2478
Insufficient Information 2108 7127
Appropriate Term/Code Not Available 1454 1455
Detachment of Device or Device Component 1070 1073
Break 1036 1038
Device Dislodged or Dislocated 765 4916
Device Appears to Trigger Rejection 761 761
Migration 622 630
Difficult to Insert 471 472
Patient Device Interaction Problem 364 366
Mechanical Problem 343 343
Patient-Device Incompatibility 313 315
Osseointegration Problem 299 11289
Noise, Audible 236 241
Tear, Rip or Hole in Device Packaging 226 227
Loose or Intermittent Connection 219 220
Crack 216 219
Positioning Failure 193 194
Use of Device Problem 169 170
Loss of Osseointegration 145 154
Device Contaminated During Manufacture or Shipping 142 144
Inadequacy of Device Shape and/or Size 139 141
Malposition of Device 134 12551
Material Erosion 133 16908
No Apparent Adverse Event 132 133
Packaging Problem 124 124
Failure to Cut 115 119
Improper or Incorrect Procedure or Method 90 6986
Lack of Effect 88 88
Difficult to Open or Remove Packaging Material 87 87
Degraded 86 118
Off-Label Use 81 81
Device-Device Incompatibility 80 80
Delivered as Unsterile Product 76 76
Material Deformation 70 70
Connection Problem 65 65
Biocompatibility 63 63
Unintended Movement 61 62
Mechanical Jam 58 58
Corroded 56 56
Device Damaged Prior to Use 55 56
Manufacturing, Packaging or Shipping Problem 54 55
Failure to Osseointegrate 42 42
Peeled/Delaminated 40 40
Material Fragmentation 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12870 23788
No Clinical Signs, Symptoms or Conditions 7917 7941
Joint Laxity 7501 24357
Unspecified Infection 6771 23575
Insufficient Information 6611 27475
Failure of Implant 6445 6484
Swelling/ Edema 4084 4108
Osteolysis 3171 14167
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2905 2909
Loss of Range of Motion 2801 7320
Ambulation Difficulties 2572 2589
Synovitis 2505 9147
Discomfort 1838 1842
Implant Pain 1829 1831
Fall 1136 1154
Scar Tissue 1134 1136
Bone Fracture(s) 955 13341
Adhesion(s) 943 946
Muscular Rigidity 794 806
Unspecified Tissue Injury 713 717
Inadequate Osseointegration 626 629
Joint Dislocation 596 16898
Inflammation 556 558
Balance Problems 502 502
Metal Related Pathology 451 7090
Cyst(s) 330 331
Thrombosis/Thrombus 308 1089
Hypersensitivity/Allergic reaction 304 305
Wound Dehiscence 297 320
Limb Fracture 286 289
Emotional Changes 276 276
Bacterial Infection 266 266
Fluid Discharge 260 262
Muscle/Tendon Damage 256 256
Unspecified Musculoskeletal problem 230 230
Hematoma 222 431
Foreign Body Reaction 211 212
Hemorrhage/Bleeding 191 193
Muscle Weakness 167 167
Impaired Healing 155 364
Arthralgia 152 11398
Ossification 141 6778
Post Operative Wound Infection 135 167
Fibrosis 135 136
Damage to Ligament(s) 131 132
Osteopenia/ Osteoporosis 129 129
Joint Contracture 126 126
Sepsis 125 126
Necrosis 118 6757
Subluxation 108 111

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 Feb-24-2026
14 Encore Medical, LP II Feb-02-2026
15 Encore Medical, LP II Aug-08-2025
16 Encore Medical, LP II Jul-17-2025
17 Encore Medical, LP II Dec-26-2024
18 Encore Medical, LP II Dec-23-2024
19 Encore Medical, LP II Oct-12-2023
20 Encore Medical, LP II Sep-19-2023
21 Encore Medical, LP II Feb-27-2023
22 Encore Medical, LP II Jun-09-2022
23 Encore Medical, LP II Jul-20-2021
24 Encore Medical, LP II Apr-30-2021
25 Exactech, Inc. II Jun-18-2024
26 Exactech, Inc. II Jan-18-2024
27 Exactech, Inc. II Oct-04-2021
28 Howmedica Osteonics Corp. II Oct-07-2024
29 Howmedica Osteonics Corp. II Jan-31-2024
30 Howmedica Osteonics Corp. II Jun-03-2022
31 Howmedica Osteonics Corp. II Aug-19-2021
32 Howmedica Osteonics Corp. II Apr-09-2021
33 Limacorporate S.p.A II Dec-09-2023
34 Linkbio Corp. II Jun-01-2023
35 Materialise N.V. II Jul-20-2023
36 Smith & Nephew Inc II Oct-31-2024
37 Smith & Nephew Inc II Oct-30-2024
38 Smith & Nephew Inc II Sep-20-2023
39 Smith & Nephew Inc II May-16-2022
40 Smith & Nephew, Inc. II Oct-24-2023
41 Smith & Nephew, Inc. II Jul-20-2022
42 Smith & Nephew, Inc. II Jun-24-2021
43 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-08-2025
44 Waldemar Link GmbH & Co. KG (Mfg Site) II Apr-30-2025
45 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-17-2025
46 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-18-2024
47 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-03-2023
48 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
49 Zimmer, Inc. II Mar-24-2025
50 Zimmer, Inc. II Jan-28-2025
51 Zimmer, Inc. II Apr-22-2024
52 Zimmer, Inc. II Jul-05-2023
53 Zimmer, Inc. II Dec-09-2022
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