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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, ankle, semi-constrained, cemented, metal/polymer
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 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KINOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 9

MDR Year MDR Reports MDR Events
2017 96 96
2018 185 185
2019 277 277
2020 281 281
2021 237 237
2022 354 354

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 865 865
Insufficient Information 100 100
Migration 98 98
Loss of Osseointegration 59 59
Break 46 46
Loosening of Implant Not Related to Bone-Ingrowth 45 45
Fracture 35 35
Migration or Expulsion of Device 30 30
Loss of or Failure to Bond 28 28
Device Dislodged or Dislocated 28 28
Appropriate Term/Code Not Available 26 26
Use of Device Problem 22 22
Improper or Incorrect Procedure or Method 15 15
Naturally Worn 15 15
Loose or Intermittent Connection 13 13
Osseointegration Problem 11 11
Malposition of Device 9 9
Patient Device Interaction Problem 9 9
Unintended Movement 9 9
Unstable 8 8
Mechanical Problem 8 8
Disassembly 8 8
Device Inoperable 7 7
Mechanical Jam 7 7
Patient-Device Incompatibility 6 6
Detachment of Device or Device Component 6 6
Device Operates Differently Than Expected 6 6
Component Missing 6 6
Collapse 5 5
Positioning Problem 4 4
No Apparent Adverse Event 3 3
Noise, Audible 3 3
Inaccurate Information 3 3
Degraded 3 3
Material Erosion 3 3
Difficult To Position 3 3
Device Difficult to Setup or Prepare 2 2
Nonstandard Device 2 2
Peeled/Delaminated 2 2
Positioning Failure 2 2
Missing Information 2 2
Device-Device Incompatibility 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 1 1
Device Markings/Labelling Problem 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Disintegration 1 1
Material Fragmentation 1 1
Difficult or Delayed Positioning 1 1
Bent 1 1
Component Incompatible 1 1
Contamination 1 1
Failure to Osseointegrate 1 1
Failure to Align 1 1
Defective Device 1 1
Unsealed Device Packaging 1 1
Misassembled 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 317 317
Injury 180 180
Pain 174 174
No Code Available 160 160
Unspecified Infection 152 152
No Known Impact Or Consequence To Patient 104 104
No Clinical Signs, Symptoms or Conditions 91 91
Failure of Implant 84 84
Patient Problem/Medical Problem 78 78
Bone Fracture(s) 68 68
Osteolysis 55 55
Cyst(s) 53 53
Implant Pain 50 50
Impaired Healing 47 47
Loss of Range of Motion 35 35
Inadequate Osseointegration 33 33
Swelling/ Edema 30 30
Swelling 28 28
No Information 27 27
Post Operative Wound Infection 24 24
Ossification 22 22
Wound Dehiscence 18 18
Ambulation Difficulties 16 16
Discomfort 14 14
Joint Dislocation 13 13
Erythema 13 13
Bacterial Infection 11 11
Joint Laxity 11 11
Numbness 11 11
Arthritis 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Tissue Damage 9 9
Depression 9 9
Anxiety 9 9
Osteopenia/ Osteoporosis 9 9
Limited Mobility Of The Implanted Joint 9 9
Joint Disorder 8 8
Unspecified Tissue Injury 8 8
Not Applicable 7 7
Inflammation 7 7
Scar Tissue 6 6
Fall 6 6
Purulent Discharge 6 6
Non-union Bone Fracture 5 5
No Consequences Or Impact To Patient 5 5
Burning Sensation 4 4
Deformity/ Disfigurement 4 4
Rheumatoid Arthritis 4 4
Damage to Ligament(s) 4 4
Foreign Body Reaction 4 4
Necrosis 4 4
Muscular Rigidity 3 3
Adhesion(s) 3 3
Ecchymosis 3 3
Fatigue 3 3
Thrombosis 3 3
Device Embedded In Tissue or Plaque 3 3
Subluxation 3 3
Malunion of Bone 3 3
Metal Related Pathology 2 2
Debris, Bone Shedding 2 2
Nerve Damage 2 2
Sepsis 2 2
Skin Irritation 1 1
Visual Disturbances 1 1
Tachycardia 1 1
Aneurysm 1 1
Aspiration/Inhalation 1 1
Fever 1 1
Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Ankylosis 1 1
Limb Fracture 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Joint Swelling 1 1
Collapse 1 1
Fungal Infection 1 1
Reaction 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 Wright Medical Technology Inc II Dec-01-2021
7 Wright Medical Technology Inc II May-07-2020
8 Wright Medical Technology, Inc. II Oct-27-2022
9 Wright Medical Technology, Inc. II Jun-27-2022
10 Wright Medical Technology, Inc. II Nov-25-2019
11 Zimmer Biomet, Inc. II Nov-07-2019
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