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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Description Ankle joint metal/polymer semi-constrained cemented prosthesis.
Product CodeHSN
Regulation Number 888.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
ASCENSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
DT MEDTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 2
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KINOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 10

MDR Year MDR Reports MDR Events
2016 110 110
2017 96 96
2018 185 185
2019 277 277
2020 281 281
2021 152 152

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 559 559
Insufficient Information 133 133
Migration 56 56
Loss of Osseointegration 46 46
Migration or Expulsion of Device 39 39
Fracture 32 32
Loss of or Failure to Bond 28 28
Break 27 27
Loosening of Implant Not Related to Bone-Ingrowth 27 27
Appropriate Term/Code Not Available 24 24
Device Dislodged or Dislocated 24 24
Use of Device Problem 18 18
Loose or Intermittent Connection 16 16
Improper or Incorrect Procedure or Method 15 15
Naturally Worn 12 12
Malposition of Device 11 11
Device Inoperable 10 10
Disassembly 10 10
Device Operates Differently Than Expected 9 9
Unstable 9 9
Failure To Adhere Or Bond 8 8
Mechanical Problem 8 8
Patient-Device Incompatibility 7 7
Patient Device Interaction Problem 7 7
Positioning Problem 6 6
Unintended Movement 6 6
Noise, Audible 5 5
Detachment of Device or Device Component 5 5
Mechanical Jam 5 5
Collapse 5 5
Degraded 3 3
Difficult To Position 3 3
Device Slipped 3 3
Failure to Osseointegrate 3 3
Component Missing 3 3
Radiation Overexposure 3 3
Material Erosion 3 3
Device-Device Incompatibility 2 2
Compatibility Problem 2 2
Material Integrity Problem 2 2
Missing Information 2 2
Peeled/Delaminated 2 2
Metal Shedding Debris 2 2
No Apparent Adverse Event 2 2
Positioning Failure 2 2
Material Disintegration 1 1
Component Incompatible 1 1
Loss of Power 1 1
Material Separation 1 1
Unsealed Device Packaging 1 1
Bent 1 1
Material Fragmentation 1 1
Hole In Material 1 1
Patient Data Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Twisted/Bent 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Partial Blockage 1 1
Contamination 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Difficult or Delayed Positioning 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 183 183
Pain 181 181
Injury 181 181
Unspecified Infection 140 140
No Known Impact Or Consequence To Patient 117 117
Patient Problem/Medical Problem 90 90
Insufficient Information 85 85
Bone Fracture(s) 63 63
No Clinical Signs, Symptoms or Conditions 59 59
Failure of Implant 53 53
Osteolysis 46 46
Impaired Healing 45 45
No Information 39 39
Cyst(s) 30 30
Swelling 29 29
Loss of Range of Motion 27 27
Ossification 21 21
Discomfort 15 15
Inadequate Osseointegration 14 14
Limited Mobility Of The Implanted Joint 13 13
Post Operative Wound Infection 13 13
Implant Pain 11 11
Tissue Damage 11 11
Ambulation Difficulties 11 11
Joint Dislocation 10 10
Arthritis 9 9
Depression 9 9
Anxiety 9 9
Joint Disorder 8 8
Erythema 8 8
Numbness 8 8
Inadequate Pain Relief 7 7
Not Applicable 7 7
Swelling/ Edema 6 6
Scar Tissue 6 6
Osteopenia/ Osteoporosis 6 6
No Consequences Or Impact To Patient 6 6
Wound Dehiscence 6 6
Muscular Rigidity 5 5
Necrosis 4 4
Burning Sensation 4 4
Bacterial Infection 4 4
Adhesion(s) 3 3
Ecchymosis 3 3
Reaction 3 3
Device Embedded In Tissue or Plaque 3 3
Non-union Bone Fracture 3 3
Joint Laxity 3 3
Abscess 3 3
Fatigue 3 3
Thrombosis 3 3
Staphylococcus Aureus 3 3
Skin Irritation 3 3
Fall 2 2
Foreign Body Reaction 2 2
Debris, Bone Shedding 2 2
Nerve Damage 2 2
Tachycardia 1 1
Edema 1 1
Complaint, Ill-Defined 1 1
Joint Swelling 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Ankylosis 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Aneurysm 1 1
Rheumatoid Arthritis 1 1
Aspiration/Inhalation 1 1
Sepsis 1 1
Visual Disturbances 1 1
Rash 1 1
Inflammation 1 1
Collapse 1 1
Fungal Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Oct-04-2021
2 Exactech, Inc. II Aug-31-2020
3 Exactech, Inc. II Dec-06-2017
4 Integra LifeSciences Corp. II Apr-16-2019
5 Integra LifeSciences Corp. II Feb-11-2017
6 Integra LifeSciences Corp. II Jun-29-2016
7 Wright Medical Technology Inc II May-07-2020
8 Wright Medical Technology, Inc. II Nov-25-2019
9 Zimmer Biomet, Inc. II Nov-07-2019
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