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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Product CodeJWH
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO CORP.
  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 6
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
CPM MEDICAL CONSULTANTS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 4
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
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 2
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 4
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
MIRCOPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
PRECISION CASTING SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STABIL ORTHOPAEDIC SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS (AKA HOWMEDICA OSTEONICS CORP.)
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC.
  SUBSTANTIALLY EQUIVALENT 1
TJC LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNIK ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 14986 14986
2020 12591 12591
2021 9406 9406
2022 8360 8360
2023 8979 8985
2024 8996 9212

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25539 25671
Fracture 6197 6197
Naturally Worn 4953 4975
Insufficient Information 4675 4675
Loss of or Failure to Bond 4328 4328
Loosening of Implant Not Related to Bone-Ingrowth 3975 4011
Appropriate Term/Code Not Available 2538 2538
Break 2477 2477
Unstable 1921 1921
Detachment of Device or Device Component 1339 1339
Device Dislodged or Dislocated 1022 1022
Migration 972 972
Loose or Intermittent Connection 748 748
Noise, Audible 610 610
Patient Device Interaction Problem 604 604
Difficult to Insert 527 527
Device Appears to Trigger Rejection 436 436
Malposition of Device 390 390
Crack 368 368
Use of Device Problem 337 337
Loss of Osseointegration 296 296
Component Missing 274 274
Scratched Material 262 262
Osseointegration Problem 258 258
Inadequacy of Device Shape and/or Size 257 257
Tear, Rip or Hole in Device Packaging 244 244
Unintended Movement 244 244
Physical Resistance/Sticking 228 228
Positioning Failure 203 203
Material Deformation 196 196
Mechanical Problem 165 165
Packaging Problem 165 165
Device Contaminated During Manufacture or Shipping 157 157
Material Twisted/Bent 152 152
Device-Device Incompatibility 146 146
No Apparent Adverse Event 138 138
Patient-Device Incompatibility 138 138
Fitting Problem 137 137
Material Erosion 130 130
Connection Problem 130 130
Corroded 115 115
Failure to Cut 115 115
Migration or Expulsion of Device 115 115
Off-Label Use 97 97
Delivered as Unsterile Product 82 82
Improper or Incorrect Procedure or Method 81 81
Difficult to Open or Remove Packaging Material 78 78
Mechanical Jam 78 78
Degraded 74 106
Manufacturing, Packaging or Shipping Problem 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15634 15682
No Code Available 10929 10929
Unspecified Infection 9071 9071
No Clinical Signs, Symptoms or Conditions 6965 6987
Failure of Implant 6102 6102
Joint Laxity 4610 4610
Insufficient Information 4492 4642
Swelling/ Edema 2703 2709
Injury 2654 2654
Loss of Range of Motion 2588 2630
No Consequences Or Impact To Patient 2198 2198
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2070 2070
Adhesion(s) 1833 1833
Osteolysis 1789 1789
Ambulation Difficulties 1773 1775
No Known Impact Or Consequence To Patient 1716 1716
No Information 1509 1509
Bone Fracture(s) 1417 1417
No Patient Involvement 1187 1187
Synovitis 1167 1167
Fall 1160 1160
Discomfort 1072 1072
Limited Mobility Of The Implanted Joint 1034 1034
Muscular Rigidity 991 991
Implant Pain 947 947
Swelling 878 878
Scar Tissue 741 741
Edema 737 737
Joint Dislocation 677 678
Inadequate Osseointegration 616 616
Inflammation 571 571
Joint Disorder 521 521
Unspecified Tissue Injury 505 505
Hematoma 389 389
Wound Dehiscence 388 388
Hypersensitivity/Allergic reaction 376 376
Bacterial Infection 345 345
Thrombosis 318 318
Not Applicable 312 312
Fibrosis 288 288
Hemorrhage/Bleeding 280 280
Thrombosis/Thrombus 264 264
Pulmonary Embolism 251 251
Foreign Body Reaction 250 250
Impaired Healing 232 232
Metal Related Pathology 230 230
Tissue Damage 199 199
Cyst(s) 197 197
Muscle/Tendon Damage 194 194
Emotional Changes 193 193

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 Conformis, Inc. II Apr-17-2024
8 Conformis, Inc. II Apr-08-2022
9 Conformis, Inc. II Aug-22-2020
10 Conformis, Inc. II Apr-01-2020
11 Conformis, Inc. II Dec-12-2019
12 Conformis, Inc. II Apr-08-2019
13 Conformis, Inc. II Mar-30-2019
14 Corin Ltd II Nov-02-2023
15 Corin Ltd II Nov-21-2022
16 DePuy Orthopaedics, Inc. II Feb-09-2022
17 DePuy Orthopaedics, Inc. II Oct-07-2021
18 DePuy Orthopaedics, Inc. II Aug-25-2021
19 DePuy Orthopaedics, Inc. II Mar-29-2021
20 DePuy Orthopaedics, Inc. II Feb-09-2021
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 Exactech, Inc. II Apr-23-2019
32 Howmedica Osteonics Corp. II Oct-07-2024
33 Howmedica Osteonics Corp. II Jan-31-2024
34 Howmedica Osteonics Corp. II Jun-03-2022
35 Howmedica Osteonics Corp. II Aug-19-2021
36 Howmedica Osteonics Corp. II Apr-09-2021
37 Limacorporate S.p.A II Dec-09-2023
38 Linkbio Corp. II Jun-01-2023
39 Materialise N.V. II Jul-20-2023
40 Ortho Development Corporation II May-06-2020
41 Signature Orthopedics Pty Limited II Feb-14-2019
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 Smith & Nephew, Inc. II Sep-12-2019
53 Smith & Nephew, Inc. II Mar-22-2019
54 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-18-2024
55 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-03-2023
56 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
57 Zimmer Biomet, Inc. II Nov-07-2019
58 Zimmer Biomet, Inc. II Sep-12-2019
59 Zimmer Biomet, Inc. II Apr-04-2019
60 Zimmer Biomet, Inc. II Feb-23-2019
61 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
62 Zimmer, Inc. II Apr-22-2024
63 Zimmer, Inc. II Jul-05-2023
64 Zimmer, Inc. II Dec-09-2022
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