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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 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 542 542
2018 614 614
2019 759 759
2020 749 749
2021 763 763

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 964 964
Insufficient Information 747 747
Fracture 314 314
Loss of Osseointegration 195 195
Device Dislodged or Dislocated 171 171
Appropriate Term/Code Not Available 147 147
Unstable 144 144
Break 138 138
Detachment of Device or Device Component 125 125
Loosening of Implant Not Related to Bone-Ingrowth 100 100
Migration or Expulsion of Device 75 75
Naturally Worn 74 74
Loose or Intermittent Connection 66 66
Patient Device Interaction Problem 52 52
Mechanical Problem 43 43
Migration 38 38
Failure to Advance 36 36
Compatibility Problem 26 26
Unintended Movement 26 26
Disassembly 24 24
Malposition of Device 23 23
Packaging Problem 23 23
Noise, Audible 21 21
Degraded 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 15 15
Component Missing 15 15
Detachment Of Device Component 14 14
Loss of or Failure to Bond 14 14
Material Fragmentation 11 11
Delivered as Unsterile Product 11 11
Tear, Rip or Hole in Device Packaging 11 11
Use of Device Problem 11 11
Material Integrity Problem 10 10
Connection Problem 9 9
Unsealed Device Packaging 9 9
Material Erosion 9 9
Crack 9 9
Device Operates Differently Than Expected 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Difficult to Insert 7 7
Metal Shedding Debris 7 7
Device Slipped 7 7
Improper or Incorrect Procedure or Method 7 7
Positioning Failure 6 6
Contamination /Decontamination Problem 6 6
Device Damaged by Another Device 5 5
Scratched Material 5 5
Corroded 5 5
Component Incompatible 4 4
Failure To Adhere Or Bond 4 4
Material Disintegration 4 4
No Device Output 4 4
Product Quality Problem 4 4
Material Separation 4 4
Positioning Problem 4 4
Device-Device Incompatibility 4 4
Device Contamination with Chemical or Other Material 4 4
Device Contaminated During Manufacture or Shipping 4 4
Device Markings/Labelling Problem 3 3
Material Twisted/Bent 3 3
Activation Failure 3 3
No Apparent Adverse Event 3 3
Separation Problem 3 3
Difficult or Delayed Separation 3 3
Unclear Information 3 3
Shipping Damage or Problem 3 3
Fitting Problem 3 3
Microbial Contamination of Device 3 3
Device Issue 3 3
Expiration Date Error 3 3
Separation Failure 2 2
Biocompatibility 2 2
Failure to Align 2 2
Defective Device 2 2
Off-Label Use 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Failure to Osseointegrate 2 2
Disconnection 2 2
Activation Problem 2 2
Sharp Edges 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
Incomplete or Inadequate Connection 1 1
Unintended Compatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 803 803
Injury 576 576
Pain 483 483
No Information 379 379
Failure of Implant 279 279
No Code Available 263 263
Cancer 199 199
Inadequate Osseointegration 175 175
Insufficient Information 166 166
No Known Impact Or Consequence To Patient 121 122
Bone Fracture(s) 121 121
Joint Dislocation 97 97
Fall 88 88
Ambulation Difficulties 80 80
No Clinical Signs, Symptoms or Conditions 70 70
Swelling 65 65
Loss of Range of Motion 64 64
Limited Mobility Of The Implanted Joint 63 63
Patient Problem/Medical Problem 62 62
Joint Disorder 45 45
No Consequences Or Impact To Patient 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 44
Joint Laxity 38 38
Reaction 38 38
Inflammation 34 34
Death 25 25
Post Operative Wound Infection 23 23
Not Applicable 22 22
Unequal Limb Length 22 22
Scar Tissue 21 21
Necrosis 19 19
Bacterial Infection 18 18
Osteolysis 17 17
Hematoma 14 14
Metal Related Pathology 14 14
Wound Dehiscence 13 13
Thrombosis 13 13
Tissue Damage 13 13
Foreign Body Reaction 12 12
Unspecified Tissue Injury 11 11
Ulcer 10 10
Ossification 9 9
No Patient Involvement 9 9
Sudden Cardiac Death 8 8
Fluid Discharge 8 8
Edema 8 8
Cellulitis 7 7
Skin Discoloration 7 7
Synovitis 7 7
Staphylococcus Aureus 7 7
Device Embedded In Tissue or Plaque 7 7
Fibrosis 7 7
Foreign Body In Patient 6 6
Blood Loss 6 6
Swelling/ Edema 6 6
Post Traumatic Wound Infection 6 6
Fungal Infection 5 5
Discomfort 5 5
Discharge 5 5
Muscular Rigidity 5 5
Host-Tissue Reaction 5 5
Adhesion(s) 5 5
Damage to Ligament(s) 5 5
Muscle Weakness 4 4
Fever 4 4
Hemorrhage/Bleeding 4 4
Hypersensitivity/Allergic reaction 4 4
Rash 4 4
Hypovolemia 4 4
Viral Infection 4 4
Joint Swelling 4 4
Peroneal Nerve Palsy 4 4
Impaired Healing 4 4
Implant Pain 4 4
Muscle/Tendon Damage 4 4
Osteopenia/ Osteoporosis 4 4
Toxicity 3 3
Hip Fracture 2 2
Perforation 2 2
Scarring 2 2
Sepsis 2 2
Rupture 2 2
Abscess 2 2
Erythema 2 2
Weight Changes 2 2
Hyperextension 2 2
Subluxation 1 1
Vascular System (Circulation), Impaired 1 1
Unspecified Musculoskeletal problem 1 1
Purulent Discharge 1 1
Chest Pain 1 1
Cyst(s) 1 1
Anemia 1 1
Aortic Valve Stenosis 1 1
Arthritis 1 1
Pulmonary Embolism 1 1
Infiltration into Tissue 1 1
Necrosis Of Flap Tissue 1 1
Nerve Damage 1 1
Neuropathy 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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