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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 NV
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
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 3
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 12591 12591
2021 9408 9408
2022 8361 8361
2023 8979 8985
2024 10850 11083
2025 5037 11112

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23632 29790
Naturally Worn 5806 5828
Fracture 5691 5691
Loosening of Implant Not Related to Bone-Ingrowth 4605 6824
Loss of or Failure to Bond 3034 3034
Insufficient Information 2931 3067
Unstable 2555 2555
Appropriate Term/Code Not Available 1921 1921
Break 1701 1701
Detachment of Device or Device Component 1238 1238
Device Dislodged or Dislocated 796 874
Migration 760 760
Device Appears to Trigger Rejection 589 589
Difficult to Insert 475 475
Patient Device Interaction Problem 473 473
Loose or Intermittent Connection 399 399
Noise, Audible 348 348
Mechanical Problem 328 328
Crack 320 320
Osseointegration Problem 252 363
Tear, Rip or Hole in Device Packaging 246 246
Use of Device Problem 236 236
Malposition of Device 226 2067
Inadequacy of Device Shape and/or Size 214 214
Loss of Osseointegration 207 207
Positioning Failure 190 190
Patient-Device Incompatibility 175 175
Device Contaminated During Manufacture or Shipping 162 162
Material Erosion 140 1705
Unintended Movement 136 136
Packaging Problem 133 133
Material Deformation 117 117
Failure to Cut 115 115
Connection Problem 113 113
No Apparent Adverse Event 108 108
Off-Label Use 94 94
Difficult to Open or Remove Packaging Material 90 90
Improper or Incorrect Procedure or Method 82 82
Physical Resistance/Sticking 82 82
Corroded 81 81
Material Twisted/Bent 80 80
Degraded 78 110
Device-Device Incompatibility 75 75
Fitting Problem 68 68
Scratched Material 67 67
Manufacturing, Packaging or Shipping Problem 65 65
Mechanical Jam 65 65
Delivered as Unsterile Product 64 64
Lack of Effect 63 63
Defective Device 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 14108 14167
Unspecified Infection 7609 9994
No Clinical Signs, Symptoms or Conditions 7587 7609
Failure of Implant 6879 6881
Joint Laxity 6364 7446
Insufficient Information 5646 11634
No Code Available 4709 4709
Swelling/ Edema 3847 3853
Osteolysis 3041 3230
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2999 2999
Loss of Range of Motion 2708 3033
Ambulation Difficulties 2535 2537
Synovitis 2446 2446
Discomfort 1754 1754
Implant Pain 1714 1714
Adhesion(s) 1335 1335
Bone Fracture(s) 1217 3436
Fall 1145 1154
Scar Tissue 1137 1137
Injury 1095 1095
Muscular Rigidity 974 974
No Known Impact Or Consequence To Patient 871 871
No Consequences Or Impact To Patient 716 716
No Patient Involvement 714 714
Joint Dislocation 618 2602
Inadequate Osseointegration 600 600
Inflammation 598 598
Unspecified Tissue Injury 597 597
No Information 589 589
Limited Mobility Of The Implanted Joint 515 515
Balance Problems 493 493
Metal Related Pathology 403 403
Edema 384 384
Wound Dehiscence 366 369
Bacterial Infection 331 331
Cyst(s) 321 321
Hypersensitivity/Allergic reaction 316 316
Thrombosis/Thrombus 301 319
Hematoma 297 502
Swelling 296 296
Emotional Changes 277 277
Hemorrhage/Bleeding 258 258
Muscle/Tendon Damage 239 239
Foreign Body Reaction 224 224
Impaired Healing 215 408
Limb Fracture 214 214
Fluid Discharge 195 195
Joint Disorder 172 172
Unspecified Musculoskeletal problem 164 164
Ossification 157 157

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