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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 4
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 3
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
JUST MEDICAL DEVICES (TIANJIN) CO., LTD.
  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 7
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 3
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 9429 36697
2026 5242 6739

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23107 51869
Naturally Worn 6146 6168
Fracture 5247 19077
Loosening of Implant Not Related to Bone-Ingrowth 4571 24948
Unstable 2597 2599
Loss of or Failure to Bond 2532 2545
Insufficient Device Problem Information 2150 7177
Detachment of Device or Device Component 1097 1100
Break 1019 1020
Device Appears to Trigger Rejection 843 843
Device Dislodged or Dislocated 762 4963
Migration 649 657
Difficult to Insert 489 490
Patient-Device Incompatibility 404 404
Patient Device Interaction Problem 367 368
Appropriate Device Problem Term/Code Not Available 360 360
Mechanical Problem 346 346
Osseointegration Problem 317 14308
Tear, Rip or Hole in Device Packaging 232 233
Noise, Audible 232 237
No Apparent Adverse Event 226 227
Crack 217 220
Positioning Failure 204 205
Loss of Osseointegration 181 190
Use of Device Problem 177 178
Malposition of Device 156 16573
Device Contaminated During Manufacture or Shipping 153 155
Material Erosion 136 20146
Inadequacy of Device Shape and/or Size 134 136
Packaging Problem 122 122
Failure to Cut 112 116
Lack of Effect 101 101
Degraded 93 125
Difficult to Open or Remove Packaging Material 89 89
Delivered as Unsterile Product 88 88
Device-Device Incompatibility 86 86
Off-Label Use 85 85
Improper or Incorrect Procedure or Method 82 10185
Material Deformation 74 74
Biocompatibility 66 66
Connection Problem 64 64
Unintended Movement 62 62
Mechanical Jam 60 60
Corroded 55 55
Device Damaged Prior to Use 54 55
Manufacturing, Packaging or Shipping Problem 54 55
Failure to Osseointegrate 41 41
Peeled/Delaminated 40 40
Implant subsidence 39 45
Material Fragmentation 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 13576 34754
Joint Laxity 8120 28261
No Clinical Signs, Symptoms or Conditions 8109 8133
Unspecified Infection 7305 34575
Insufficient Information 7016 34534
Failure of Implant 6526 6565
Swelling/ Edema 4336 4360
Osteolysis 3416 24622
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2971 2975
Loss of Range of Motion 2901 7498
Ambulation or Postural Difficulties 2840 2857
Synovitis 2605 12248
Discomfort 2020 2024
Implant Pain 1906 1908
Fall 1215 1260
Joint effusion 1193 1196
Scar Tissue 1166 1168
Medical device site infection 1013 1216
Bone Fracture(s) 983 15986
Adhesion(s) 972 975
Aseptic loosening 917 28288
Muscular Rigidity 841 853
Unspecified Tissue Injury 759 763
Inadequate Osseointegration 682 685
Joint Dislocation 634 27223
Inflammation 583 585
Balance Problems 502 502
Metal Related Pathology 496 10136
Cyst(s) 346 347
Hypersensitivity/Allergic reaction 325 326
Thrombosis/Thrombus 320 1101
Wound Dehiscence 310 333
Limb Fracture 293 296
Emotional Changes 276 276
Arthrofibrosis 275 17563
Bacterial Infection 274 274
Muscle/Tendon Damage 268 295
Unspecified Musculoskeletal problem 258 258
Fluid Discharge 236 238
Hematoma 224 433
Foreign Body Reaction 214 215
Hemorrhage/Blood Loss/Bleeding 200 202
Muscle Weakness/Atrophy 170 170
Impaired Healing 164 373
Arthralgia 159 14612
Post Operative Wound Infection 148 180
Extraskeletal ossification 147 9785
Damage to Ligament(s) 138 139
Fibrosis 136 137
Osteopenia/ Osteoporosis 132 132

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