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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
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
LINK BIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
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
2018 614 614
2019 759 759
2020 749 749
2021 767 767
2022 897 897

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1343 1343
Insufficient Information 605 605
Fracture 375 375
Loss of Osseointegration 233 233
Device Dislodged or Dislocated 175 175
Unstable 160 160
Detachment of Device or Device Component 142 142
Appropriate Term/Code Not Available 140 140
Loosening of Implant Not Related to Bone-Ingrowth 134 134
Break 126 126
Naturally Worn 113 113
Loose or Intermittent Connection 61 61
Patient Device Interaction Problem 54 54
Mechanical Problem 50 50
Migration 48 48
Failure to Advance 45 45
Degraded 42 42
Migration or Expulsion of Device 37 37
Unintended Movement 27 27
Compatibility Problem 26 26
Osseointegration Problem 23 23
Patient-Device Incompatibility 20 20
Device Appears to Trigger Rejection 19 19
Inadequacy of Device Shape and/or Size 17 17
Packaging Problem 17 17
Malposition of Device 17 17
Noise, Audible 15 15
Material Deformation 15 15
Separation Failure 15 15
Material Fragmentation 12 12
Mechanical Jam 12 12
Component Missing 12 12
Loss of or Failure to Bond 12 12
Material Erosion 12 12
Use of Device Problem 11 11
Crack 10 10
Delivered as Unsterile Product 10 10
Connection Problem 9 9
Unsealed Device Packaging 9 9
Material Integrity Problem 9 9
Detachment Of Device Component 9 9
Improper or Incorrect Procedure or Method 9 9
Tear, Rip or Hole in Device Packaging 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Disassembly 8 8
Shipping Damage or Problem 7 7
No Apparent Adverse Event 7 7
Contamination /Decontamination Problem 7 7
Device Slipped 6 6
Difficult to Insert 5 5
Device Contaminated During Manufacture or Shipping 5 5
Corroded 5 5
Component Incompatible 5 5
Positioning Failure 4 4
Material Disintegration 4 4
Device Damaged by Another Device 4 4
Material Separation 4 4
Failure to Osseointegrate 4 4
Device-Device Incompatibility 4 4
Positioning Problem 4 4
Scratched Material 3 3
Activation Failure 3 3
Sharp Edges 3 3
No Device Output 3 3
Microbial Contamination of Device 3 3
Separation Problem 3 3
Difficult or Delayed Separation 3 3
Fitting Problem 3 3
Defective Component 3 3
Expiration Date Error 3 3
Material Twisted/Bent 3 3
Unclear Information 3 3
Operating System Becomes Nonfunctional 2 2
Device Handling Problem 2 2
Off-Label Use 2 2
Device Contamination with Chemical or Other Material 2 2
Product Quality Problem 2 2
Activation Problem 2 2
Failure to Align 2 2
Defective Device 2 2
Device Difficult to Setup or Prepare 2 2
Nonstandard Device 2 2
Biocompatibility 2 2
Material Rupture 2 2
Device Damaged Prior to Use 2 2
Disconnection 2 2
Electrical /Electronic Property Problem 1 1
Material Frayed 1 1
Difficult or Delayed Activation 1 1
Ambient Noise Problem 1 1
Material Distortion 1 1
Device Unsafe to Use in Environment 1 1
Unintended Compatibility 1 1
Metal Shedding Debris 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1
Collapse 1 1
Difficult to Open or Remove Packaging Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1134 1134
Injury 538 538
Pain 476 476
Insufficient Information 416 416
Failure of Implant 368 368
No Information 240 240
Inadequate Osseointegration 221 221
No Code Available 220 220
Cancer 147 147
No Clinical Signs, Symptoms or Conditions 130 130
Ambulation Difficulties 128 128
Bone Fracture(s) 122 122
Fall 117 117
Joint Dislocation 92 92
No Known Impact Or Consequence To Patient 92 93
Joint Laxity 73 73
Loss of Range of Motion 68 68
Patient Problem/Medical Problem 59 59
Swelling 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Limited Mobility Of The Implanted Joint 42 42
Joint Disorder 40 40
Unequal Limb Length 40 40
Inflammation 39 39
Scar Tissue 34 34
Swelling/ Edema 28 28
No Consequences Or Impact To Patient 27 27
Reaction 25 25
Death 24 24
Metal Related Pathology 23 23
Not Applicable 22 22
Hematoma 19 19
Post Operative Wound Infection 19 19
Osteolysis 18 18
Wound Dehiscence 16 16
Bacterial Infection 15 15
Foreign Body Reaction 14 14
Unspecified Tissue Injury 14 14
Muscular Rigidity 12 12
Tissue Damage 11 11
Fluid Discharge 11 11
Thrombosis 10 10
Ulcer 10 10
Synovitis 10 10
Necrosis 9 9
Edema 8 8
Post Traumatic Wound Infection 8 8
Ossification 8 8
Adhesion(s) 8 8
Discomfort 8 8
No Patient Involvement 8 8
Sudden Cardiac Death 8 8
Hyperextension 7 7
Skin Discoloration 7 7
Staphylococcus Aureus 7 7
Implant Pain 7 7
Joint Contracture 6 6
Hemorrhage/Bleeding 6 6
Damage to Ligament(s) 6 6
Muscle/Tendon Damage 6 6
Blood Loss 6 6
Osteopenia/ Osteoporosis 5 5
Foreign Body In Patient 5 5
Discharge 4 4
Hypovolemia 4 4
Fever 4 4
Rash 4 4
Host-Tissue Reaction 4 4
Impaired Healing 4 4
Rupture 3 3
Sepsis 3 3
Hip Fracture 3 3
Hypersensitivity/Allergic reaction 3 3
Joint Swelling 3 3
Abdominal Pain 2 2
Stroke/CVA 2 2
Subluxation 2 2
Weight Changes 2 2
Toxicity 2 2
Fungal Infection 2 2
Erythema 2 2
Abscess 2 2
Anemia 2 2
Scarring 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Musculoskeletal problem 1 1
Tissue Breakdown 1 1
Nerve Damage 1 1
Chest Pain 1 1
Fistula 1 1
Granuloma 1 1
Weakness 1 1
Distress 1 1
Aortic Valve Stenosis 1 1
Infiltration into Tissue 1 1
Neuropathy 1 1
Perforation 1 1
Malunion of Bone 1 1
Vascular System (Circulation), Impaired 1 1
Cellulitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Mar-19-2018
2 Uoc Usa Inc II Oct-14-2021
3 Zimmer Biomet, Inc. II Dec-07-2018
4 Zimmer Biomet, Inc. II Feb-26-2018
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