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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Product CodeKRO
Regulation Number 888.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY(IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 3
LINKBIO CORP
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WALDEMAR LINK GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 759 759
2020 749 749
2021 770 774
2022 892 910
2023 746 759
2024 855 859
2025 841 1508

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2432 3109
Insufficient Information 679 683
Fracture 567 619
Loss of Osseointegration 302 304
Loosening of Implant Not Related to Bone-Ingrowth 285 933
Device Dislodged or Dislocated 227 272
Detachment of Device or Device Component 208 211
Unstable 195 196
Naturally Worn 152 153
Appropriate Term/Code Not Available 136 136
Device Appears to Trigger Rejection 106 106
Break 92 92
Patient Device Interaction Problem 80 81
Patient-Device Incompatibility 79 79
Mechanical Problem 71 71
Migration 64 66
Degraded 64 64
Osseointegration Problem 59 85
Loose or Intermittent Connection 58 58
Failure to Advance 50 50
Unintended Movement 42 43
Compatibility Problem 26 26
Malposition of Device 24 560
Use of Device Problem 22 22
Separation Failure 21 21
Material Erosion 20 620
Inadequacy of Device Shape and/or Size 19 20
Improper or Incorrect Procedure or Method 18 18
Packaging Problem 16 16
Mechanical Jam 15 15
Delivered as Unsterile Product 15 15
Noise, Audible 14 15
Tear, Rip or Hole in Device Packaging 14 15
Loss of or Failure to Bond 13 13
Corroded 13 13
No Apparent Adverse Event 13 13
Component Missing 13 13
Material Fragmentation 12 12
Migration or Expulsion of Device 12 12
Crack 11 11
Material Deformation 11 11
Shipping Damage or Problem 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Material Integrity Problem 9 9
Activation Failure 9 9
Failure to Osseointegrate 9 9
Connection Problem 9 9
Off-Label Use 8 8
Positioning Failure 8 8
Unsealed Device Packaging 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1490 2159
Insufficient Information 878 1535
Failure of Implant 616 629
Pain 609 647
Injury 360 360
Inadequate Osseointegration 297 297
Joint Laxity 256 924
No Clinical Signs, Symptoms or Conditions 224 226
Ambulation Difficulties 201 203
Joint Dislocation 196 733
No Code Available 174 174
Bone Fracture(s) 162 803
No Information 151 151
Fall 146 146
Cancer 118 118
Loss of Range of Motion 111 222
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 94 94
No Known Impact Or Consequence To Patient 66 67
Implant Pain 62 64
Unequal Limb Length 58 59
Scar Tissue 58 60
Swelling/ Edema 55 57
Metal Related Pathology 49 50
Patient Problem/Medical Problem 48 48
Inflammation 43 46
Swelling 42 42
Unspecified Tissue Injury 39 39
Adhesion(s) 34 34
Hematoma 34 97
Joint Disorder 30 30
Limited Mobility Of The Implanted Joint 26 26
Fluid Discharge 25 26
Bacterial Infection 23 24
Wound Dehiscence 23 24
Hyperextension 23 23
Death 23 23
Osteolysis 22 153
Muscle/Tendon Damage 22 23
Muscular Rigidity 20 21
Hypersensitivity/Allergic reaction 19 21
Post Operative Wound Infection 19 19
Synovitis 18 19
Reaction 18 18
Foreign Body Reaction 18 18
No Consequences Or Impact To Patient 14 14
Osteopenia/ Osteoporosis 13 13
Ossification 12 12
Joint Contracture 12 12
Post Traumatic Wound Infection 10 10
Peripheral Nervous Injury 10 10

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-17-2023
2 Linkbio Corp. II May-04-2023
3 Onkos Surgical, Inc. II May-29-2025
4 Onkos Surgical, Inc. II May-28-2025
5 United Orthopedic Corporation II Feb-29-2024
6 Uoc Usa Inc II Oct-14-2021
7 Waldemar Link GmbH & Co. KG (Mfg Site) II Jun-30-2023
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