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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 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 5
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 3
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 N.V.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 4
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 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 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2020 12592 12600
2021 9408 9415
2022 8361 8369
2023 8947 8956
2024 10828 11039
2025 7880 22446

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25316 39889
Naturally Worn 6020 6033
Fracture 5881 11406
Loosening of Implant Not Related to Bone-Ingrowth 4798 13989
Loss of or Failure to Bond 3174 3175
Insufficient Information 3039 5831
Unstable 2705 2705
Appropriate Term/Code Not Available 1933 1935
Break 1719 1720
Detachment of Device or Device Component 1273 1273
Device Dislodged or Dislocated 845 1501
Migration 783 783
Device Appears to Trigger Rejection 671 671
Difficult to Insert 499 499
Patient Device Interaction Problem 480 481
Loose or Intermittent Connection 399 401
Mechanical Problem 361 361
Noise, Audible 353 353
Crack 323 323
Osseointegration Problem 279 6015
Tear, Rip or Hole in Device Packaging 249 249
Use of Device Problem 243 243
Malposition of Device 242 8631
Patient-Device Incompatibility 235 237
Loss of Osseointegration 231 238
Inadequacy of Device Shape and/or Size 219 220
Positioning Failure 205 205
Device Contaminated During Manufacture or Shipping 169 169
Material Erosion 150 9406
Packaging Problem 137 137
Unintended Movement 135 136
Material Deformation 121 121
Failure to Cut 115 115
Connection Problem 113 113
No Apparent Adverse Event 113 113
Off-Label Use 98 98
Difficult to Open or Remove Packaging Material 94 94
Degraded 88 120
Improper or Incorrect Procedure or Method 85 5218
Corroded 83 83
Physical Resistance/Sticking 82 82
Device-Device Incompatibility 82 82
Material Twisted/Bent 81 81
Delivered as Unsterile Product 75 75
Mechanical Jam 68 68
Fitting Problem 68 68
Lack of Effect 67 67
Scratched Material 67 67
Manufacturing, Packaging or Shipping Problem 65 65
Device Damaged Prior to Use 63 63

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 14762 20386
Unspecified Infection 8150 17427
No Clinical Signs, Symptoms or Conditions 7808 7808
Failure of Implant 6972 6999
Joint Laxity 6905 16218
Insufficient Information 6106 19429
No Code Available 4709 4711
Swelling/ Edema 4009 4019
Osteolysis 3148 8887
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3052 3053
Loss of Range of Motion 2838 3852
Ambulation Difficulties 2590 2597
Synovitis 2507 7381
Implant Pain 1810 1810
Discomfort 1793 1793
Adhesion(s) 1340 1340
Bone Fracture(s) 1276 9629
Fall 1221 1234
Scar Tissue 1167 1167
Injury 1095 1095
Muscular Rigidity 1010 1020
No Known Impact Or Consequence To Patient 871 871
No Consequences Or Impact To Patient 716 716
No Patient Involvement 714 714
Joint Dislocation 661 9442
Inadequate Osseointegration 650 650
Unspecified Tissue Injury 633 633
Inflammation 618 618
No Information 589 590
Limited Mobility Of The Implanted Joint 515 515
Balance Problems 495 495
Metal Related Pathology 430 5304
Wound Dehiscence 388 411
Edema 384 384
Bacterial Infection 345 345
Cyst(s) 338 338
Hypersensitivity/Allergic reaction 336 336
Thrombosis/Thrombus 323 1104
Hematoma 303 512
Swelling 296 297
Emotional Changes 278 279
Hemorrhage/Bleeding 263 263
Muscle/Tendon Damage 249 249
Limb Fracture 239 239
Foreign Body Reaction 235 235
Fluid Discharge 226 226
Impaired Healing 225 434
Unspecified Musculoskeletal problem 192 192
Joint Disorder 172 172
Ossification 167 5041

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