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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 5
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 13
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
CORIN U.S.A. LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CPM MEDICAL CONSULTANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 6
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 4
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 4
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 3
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 7
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 9
SUZHOU MICROPORT ORTHORECON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
THE GENERAL HOSPITAL CORPORATION, D/B/A MASSACHUSETTS
  SUBSTANTIALLY EQUIVALENT 1
TJC LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 7

MDR Year MDR Reports MDR Events
2020 12593 12603
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 28366 57129
Naturally Worn 6409 6431
Fracture 6293 20123
Loosening of Implant Not Related to Bone-Ingrowth 5223 25600
Loss of or Failure to Bond 3470 3484
Insufficient Device Problem Information 3168 8195
Unstable 2908 2910
Break 1698 1699
Detachment of Device or Device Component 1397 1400
Device Dislodged or Dislocated 929 5130
Device Appears to Trigger Rejection 852 852
Migration 840 848
Difficult to Insert 560 561
Patient Device Interaction Problem 516 517
Patient-Device Incompatibility 427 427
Appropriate Device Problem Term/Code Not Available 414 414
Mechanical Problem 372 372
Noise, Audible 357 362
Osseointegration Problem 331 14322
Crack 327 330
Loss of Osseointegration 299 308
Malposition of Device 276 16693
Use of Device Problem 267 268
Tear, Rip or Hole in Device Packaging 263 264
Positioning Failure 237 238
No Apparent Adverse Event 229 230
Inadequacy of Device Shape and/or Size 212 214
Device Contaminated During Manufacture or Shipping 188 190
Material Erosion 159 20169
Packaging Problem 142 142
Unintended Movement 138 138
Material Deformation 129 129
Failure to Cut 112 116
Connection Problem 112 112
Device-Device Incompatibility 110 110
Degraded 109 141
Off-Label Use 101 101
Lack of Effect 101 101
Difficult to Open or Remove Packaging Material 97 97
Delivered as Unsterile Product 91 91
Corroded 90 90
Improper or Incorrect Procedure or Method 83 10186
Material Twisted/Bent 81 82
Mechanical Jam 77 77
Biocompatibility 77 77
Physical Resistance/Sticking 75 75
Loose or Intermittent Connection 72 72
Scratched Material 69 69
Manufacturing, Packaging or Shipping Problem 64 65
Fitting Problem 63 63

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 16500 37681
Unspecified Infection 9376 36648
No Clinical Signs, Symptoms or Conditions 8414 8438
Joint Laxity 8364 28505
Failure of Implant 7229 7269
Insufficient Information 7181 34699
No Code Available 4710 4713
Swelling/ Edema 4494 4518
Osteolysis 3643 24849
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3162 3166
Loss of Range of Motion 3150 7747
Ambulation or Postural Difficulties 3064 3083
Synovitis 2733 12376
Discomfort 2123 2127
Implant Pain 1979 1981
Adhesion(s) 1436 1439
Fall 1426 1472
Bone Fracture(s) 1359 16362
Scar Tissue 1241 1243
Joint effusion 1194 1197
Muscular Rigidity 1122 1134
Injury 1096 1096
Medical device site infection 1013 1216
Aseptic loosening 919 28290
No Known Impact Or Consequence To Patient 871 871
Joint Dislocation 785 27375
Inadequate Osseointegration 775 778
Unspecified Tissue Injury 764 768
No Consequences Or Impact To Patient 716 716
No Patient Involvement 714 714
Inflammation 679 682
No Information 589 590
Metal Related Pathology 523 10163
Limited Mobility Of The Implanted Joint 515 515
Balance Problems 506 506
Wound Dehiscence 427 450
Cyst(s) 387 388
Edema 384 384
Hypersensitivity/Allergic reaction 383 384
Bacterial Infection 366 366
Thrombosis/Thrombus 345 1126
Hematoma 319 528
Swelling 296 297
Limb Fracture 294 297
Muscle/Tendon Damage 291 318
Hemorrhage/Blood Loss/Bleeding 291 293
Emotional Changes 278 279
Arthrofibrosis 275 17563
Foreign Body Reaction 272 273
Unspecified Musculoskeletal problem 260 260

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 CORIN MEDICAL, LTD. II Jul-02-2025
8 Conformis, Inc. II Apr-17-2024
9 Conformis, Inc. II Apr-08-2022
10 Conformis, Inc. II Aug-22-2020
11 Conformis, Inc. II Apr-01-2020
12 Corin Ltd II Nov-02-2023
13 Corin Ltd II Nov-21-2022
14 DePuy Orthopaedics, Inc. II Feb-09-2022
15 DePuy Orthopaedics, Inc. II Oct-07-2021
16 DePuy Orthopaedics, Inc. II Aug-25-2021
17 DePuy Orthopaedics, Inc. II Mar-29-2021
18 DePuy Orthopaedics, Inc. II Feb-09-2021
19 Encore Medical, LP II Jul-08-2026
20 Encore Medical, LP II Feb-24-2026
21 Encore Medical, LP II Feb-02-2026
22 Encore Medical, LP II Aug-08-2025
23 Encore Medical, LP II Jul-17-2025
24 Encore Medical, LP II Dec-26-2024
25 Encore Medical, LP II Dec-23-2024
26 Encore Medical, LP II Oct-12-2023
27 Encore Medical, LP II Sep-19-2023
28 Encore Medical, LP II Feb-27-2023
29 Encore Medical, LP II Jun-09-2022
30 Encore Medical, LP II Jul-20-2021
31 Encore Medical, LP II Apr-30-2021
32 Exactech, Inc. II Jun-18-2024
33 Exactech, Inc. II Jan-18-2024
34 Exactech, Inc. II Oct-04-2021
35 Exactech, Inc. II Feb-26-2020
36 Howmedica Osteonics Corp. II Oct-07-2024
37 Howmedica Osteonics Corp. II Jan-31-2024
38 Howmedica Osteonics Corp. II Jun-03-2022
39 Howmedica Osteonics Corp. II Aug-19-2021
40 Howmedica Osteonics Corp. II Apr-09-2021
41 Limacorporate S.p.A II Dec-09-2023
42 Linkbio Corp. II Jun-01-2023
43 Materialise N.V. II Jul-20-2023
44 Ortho Development Corporation II May-06-2020
45 Smith & Nephew Inc II Oct-31-2024
46 Smith & Nephew Inc II Oct-30-2024
47 Smith & Nephew Inc II Sep-20-2023
48 Smith & Nephew Inc II May-16-2022
49 Smith & Nephew, Inc. II Oct-24-2023
50 Smith & Nephew, Inc. II Jul-20-2022
51 Smith & Nephew, Inc. II Jun-24-2021
52 Smith & Nephew, Inc. II Oct-16-2020
53 Smith & Nephew, Inc. II Aug-08-2020
54 Smith & Nephew, Inc. II Mar-17-2020
55 United Orthopedic Corp. II Aug-05-2026
56 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-08-2025
57 Waldemar Link GmbH & Co. KG (Mfg Site) II Apr-30-2025
58 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-17-2025
59 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-18-2024
60 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-03-2023
61 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
62 Zimmer, Inc. II Mar-24-2025
63 Zimmer, Inc. II Jan-28-2025
64 Zimmer, Inc. II Apr-22-2024
65 Zimmer, Inc. II Jul-05-2023
66 Zimmer, Inc. II Dec-09-2022
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