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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
Product CodeKRO
Regulation Number 888.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
LINK BIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 542 542
2018 614 614
2019 759 759
2020 749 749
2021 767 767
2022 604 604

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1280 1280
Insufficient Information 792 792
Fracture 372 372
Loss of Osseointegration 236 236
Device Dislodged or Dislocated 191 191
Unstable 163 163
Appropriate Term/Code Not Available 154 154
Break 150 150
Detachment of Device or Device Component 137 137
Loosening of Implant Not Related to Bone-Ingrowth 125 125
Naturally Worn 108 108
Migration or Expulsion of Device 79 79
Loose or Intermittent Connection 75 75
Patient Device Interaction Problem 54 54
Mechanical Problem 51 51
Failure to Advance 43 43
Migration 43 43
Unintended Movement 32 32
Degraded 28 28
Packaging Problem 26 26
Compatibility Problem 26 26
Disassembly 24 24
Malposition of Device 24 24
Noise, Audible 21 21
Patient-Device Incompatibility 20 20
Inadequacy of Device Shape and/or Size 18 18
Osseointegration Problem 18 18
Material Deformation 17 17
Mechanical Jam 16 16
Separation Failure 15 15
Component Missing 15 15
Loss of or Failure to Bond 15 15
Detachment Of Device Component 14 14
Device Appears to Trigger Rejection 14 14
Tear, Rip or Hole in Device Packaging 12 12
Material Fragmentation 12 12
Delivered as Unsterile Product 11 11
Use of Device Problem 11 11
Crack 10 10
Material Integrity Problem 10 10
Connection Problem 10 10
Unsealed Device Packaging 9 9
Material Erosion 9 9
Difficult to Insert 8 8
Device Slipped 8 8
Improper or Incorrect Procedure or Method 8 8
Device Operates Differently Than Expected 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Metal Shedding Debris 7 7
Positioning Failure 7 7
Shipping Damage or Problem 6 6
Contamination /Decontamination Problem 6 6
No Apparent Adverse Event 6 6
Device-Device Incompatibility 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Damaged by Another Device 5 5
Scratched Material 5 5
Material Separation 5 5
Component Incompatible 5 5
Corroded 5 5
Failure To Adhere Or Bond 4 4
Material Disintegration 4 4
Product Quality Problem 4 4
No Device Output 4 4
Failure to Osseointegrate 4 4
Positioning Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Device Markings/Labelling Problem 3 3
Material Twisted/Bent 3 3
Activation Failure 3 3
Sharp Edges 3 3
Separation Problem 3 3
Difficult or Delayed Separation 3 3
Unclear Information 3 3
Defective Component 3 3
Microbial Contamination of Device 3 3
Fitting Problem 3 3
Device Issue 3 3
Expiration Date Error 3 3
Biocompatibility 2 2
Failure to Align 2 2
Defective Device 2 2
Device Damaged Prior to Use 2 2
Material Rupture 2 2
Off-Label Use 2 2
Disconnection 2 2
Activation Problem 2 2
Device Handling Problem 2 2
Operating System Becomes Nonfunctional 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Packaging Compromised 2 2
Device Operational Issue 2 2
Device Unsafe to Use in Environment 1 1
Incorrect Device Or Component Shipped 1 1
Material Protrusion/Extrusion 1 1
Material Distortion 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1065 1065
Injury 576 576
Pain 527 527
No Information 379 379
Failure of Implant 358 358
Insufficient Information 344 344
No Code Available 263 263
Inadequate Osseointegration 220 220
Cancer 200 200
Bone Fracture(s) 136 136
No Known Impact Or Consequence To Patient 121 122
Ambulation Difficulties 117 117
Fall 116 116
No Clinical Signs, Symptoms or Conditions 113 113
Joint Dislocation 102 102
Loss of Range of Motion 67 67
Swelling 65 65
Limited Mobility Of The Implanted Joint 63 63
Patient Problem/Medical Problem 62 62
Joint Laxity 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Joint Disorder 45 45
No Consequences Or Impact To Patient 44 44
Inflammation 38 38
Reaction 38 38
Unequal Limb Length 35 35
Death 25 25
Scar Tissue 24 24
Post Operative Wound Infection 23 23
Not Applicable 22 22
Swelling/ Edema 20 20
Bacterial Infection 20 20
Necrosis 19 19
Osteolysis 19 19
Metal Related Pathology 19 19
Wound Dehiscence 16 16
Hematoma 14 14
Foreign Body Reaction 13 13
Thrombosis 13 13
Tissue Damage 13 13
Unspecified Tissue Injury 11 11
Fluid Discharge 11 11
Ulcer 10 10
Ossification 10 10
Discomfort 9 9
Synovitis 9 9
No Patient Involvement 9 9
Post Traumatic Wound Infection 8 8
Sudden Cardiac Death 8 8
Muscular Rigidity 8 8
Edema 8 8
Cellulitis 7 7
Skin Discoloration 7 7
Staphylococcus Aureus 7 7
Device Embedded In Tissue or Plaque 7 7
Fibrosis 7 7
Implant Pain 6 6
Muscle/Tendon Damage 6 6
Joint Contracture 6 6
Foreign Body In Patient 6 6
Blood Loss 6 6
Adhesion(s) 6 6
Hemorrhage/Bleeding 6 6
Damage to Ligament(s) 6 6
Host-Tissue Reaction 5 5
Discharge 5 5
Osteopenia/ Osteoporosis 5 5
Impaired Healing 5 5
Fungal Infection 5 5
Hypovolemia 4 4
Viral Infection 4 4
Joint Swelling 4 4
Peroneal Nerve Palsy 4 4
Rash 4 4
Muscle Weakness 4 4
Hypersensitivity/Allergic reaction 4 4
Fever 4 4
Sepsis 3 3
Toxicity 3 3
Hip Fracture 3 3
Rupture 2 2
Perforation 2 2
Scarring 2 2
Abscess 2 2
Anemia 2 2
Erythema 2 2
Weight Changes 2 2
Hyperextension 2 2
Subluxation 2 2
Malunion of Bone 1 1
Osteomyelitis 1 1
Unspecified Musculoskeletal problem 1 1
Tissue Breakdown 1 1
Vascular System (Circulation), Impaired 1 1
Purulent Discharge 1 1
Chest Pain 1 1
Cyst(s) 1 1
Aortic Valve Stenosis 1 1
Arthritis 1 1
Pulmonary Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medacta Usa Inc II Jun-12-2017
2 Onkos Surgical, Inc. II Jun-29-2017
3 Smith & Nephew, Inc. II Mar-19-2018
4 Stanmore Implants Worldwide Ltd. II Sep-05-2017
5 Uoc Usa Inc II Oct-14-2021
6 Zimmer Biomet, Inc. II Dec-07-2018
7 Zimmer Biomet, Inc. II Feb-26-2018
8 Zimmer Biomet, Inc. II Dec-29-2017
9 Zimmer Biomet, Inc. II Nov-08-2017
10 Zimmer Biomet, Inc. II Mar-20-2017
11 Zimmer Biomet, Inc. II Jan-28-2017
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