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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
Product CodeHSN
Regulation Number 888.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
ASCENSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DT MEDTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 4
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KINOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 2
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 21
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 65 65
2015 72 72
2016 110 110
2017 96 96
2018 185 185
2019 277 277
2020 281 281
2021 237 237
2022 453 453
2023 796 796
2024 239 239

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1306 1306
Insufficient Information 500 500
Osseointegration Problem 407 407
Migration 392 392
Loss of Osseointegration 145 145
Break 89 89
Fracture 71 71
Appropriate Term/Code Not Available 63 63
Loosening of Implant Not Related to Bone-Ingrowth 59 59
Migration or Expulsion of Device 51 51
Naturally Worn 46 46
Device Dislodged or Dislocated 41 41
Malposition of Device 38 38
Loss of or Failure to Bond 28 28
Use of Device Problem 23 23
Loose or Intermittent Connection 19 19
Unstable 17 17
Detachment of Device or Device Component 17 17
Improper or Incorrect Procedure or Method 16 16
Failure to Osseointegrate 15 15
Inadequacy of Device Shape and/or Size 14 14
Device Operates Differently Than Expected 14 14
Device Difficult to Setup or Prepare 14 14
Unintended Movement 14 14
Disassembly 13 13
Patient Device Interaction Problem 12 12
Mechanical Jam 11 11
Patient-Device Incompatibility 11 11
Device Inoperable 10 10
Device Slipped 8 8
Defective Device 8 8
Positioning Failure 8 8
Failure To Adhere Or Bond 8 8
Mechanical Problem 8 8
Positioning Problem 8 8
Off-Label Use 7 7
Component Missing 6 6
Collapse 5 5
No Apparent Adverse Event 5 5
Noise, Audible 5 5
Inaccurate Information 5 5
Device Handling Problem 4 4
Degraded 4 4
Detachment Of Device Component 3 3
Material Erosion 3 3
Material Fragmentation 3 3
Difficult To Position 3 3
Device Markings/Labelling Problem 3 3
Material Deformation 3 3
Radiation Overexposure 3 3
Therapeutic or Diagnostic Output Failure 2 2
Device-Device Incompatibility 2 2
Missing Information 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Compatibility Problem 2 2
Peeled/Delaminated 2 2
Metal Shedding Debris 2 2
Entrapment of Device 2 2
Material Separation 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Misassembled 1 1
Shipping Damage or Problem 1 1
Hole In Material 1 1
Difficult to Insert 1 1
Component Falling 1 1
Component Incompatible 1 1
Contamination 1 1
Crack 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Difficult or Delayed Positioning 1 1
Bent 1 1
Partial Blockage 1 1
Material Disintegration 1 1
Residue After Decontamination 1 1
Fitting Problem 1 1
Loss of Power 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Component or Accessory Incompatibility 1 1
Failure to Align 1 1
Mechanics Altered 1 1
Missing Value Reason 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 752 752
Inadequate Osseointegration 529 529
Cyst(s) 355 355
Unspecified Infection 300 300
Pain 292 292
Implant Pain 289 289
No Code Available 202 202
Injury 181 181
Failure of Implant 157 157
Bone Fracture(s) 135 135
No Clinical Signs, Symptoms or Conditions 131 131
No Known Impact Or Consequence To Patient 126 126
Osteolysis 112 112
Patient Problem/Medical Problem 92 92
Swelling/ Edema 92 92
No Information 71 71
Loss of Range of Motion 71 71
Limb Fracture 62 62
Impaired Healing 58 58
Post Operative Wound Infection 53 53
Ossification 50 50
Ambulation Difficulties 36 36
Wound Dehiscence 35 35
Discomfort 32 32
Swelling 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Bacterial Infection 25 25
Joint Dislocation 23 23
Arthritis 21 21
Fluid Discharge 18 18
Deformity/ Disfigurement 17 17
Joint Laxity 17 17
Osteopenia/ Osteoporosis 16 16
Limited Mobility Of The Implanted Joint 15 15
Inflammation 15 15
Erythema 14 14
Numbness 14 14
Fall 13 13
Tissue Damage 11 11
Depression 9 9
Anxiety 9 9
Rheumatoid Arthritis 9 9
Joint Disorder 8 8
Foreign Body In Patient 8 8
Unspecified Tissue Injury 8 8
Not Applicable 7 7
Inadequate Pain Relief 7 7
Non-union Bone Fracture 7 7
Purulent Discharge 7 7
Damage to Ligament(s) 6 6
Foreign Body Reaction 6 6
Necrosis 6 6
Scar Tissue 6 6
Arthralgia 6 6
No Consequences Or Impact To Patient 6 6
Nerve Damage 5 5
Muscular Rigidity 5 5
Device Embedded In Tissue or Plaque 5 5
Ankylosis 5 5
Subluxation 4 4
Adhesion(s) 4 4
Burning Sensation 4 4
Synovitis 3 3
Skin Irritation 3 3
Thrombosis 3 3
Reaction 3 3
Abscess 3 3
Ecchymosis 3 3
Fatigue 3 3
Staphylococcus Aureus 3 3
Metal Related Pathology 3 3
Blister 3 3
Malunion of Bone 2 2
Sepsis 2 2
Edema 2 2
Debris, Bone Shedding 2 2
Tissue Breakdown 2 2
Complaint, Ill-Defined 2 2
Joint Swelling 1 1
Tachycardia 1 1
Rupture 1 1
Ulceration 1 1
Visual Disturbances 1 1
No Patient Involvement 1 1
Collapse 1 1
Fungal Infection 1 1
Fever 1 1
Host-Tissue Reaction 1 1
Aneurysm 1 1
Aspiration/Inhalation 1 1
Seroma 1 1
Rash 1 1
Low Blood Pressure/ Hypotension 1 1
Muscle/Tendon Damage 1 1
Fibrosis 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jan-18-2024
2 Exactech, Inc. II Oct-04-2021
3 Exactech, Inc. II Aug-31-2020
4 Exactech, Inc. II Dec-06-2017
5 Integra LifeSciences Corp. II Apr-16-2019
6 Integra LifeSciences Corp. II Feb-11-2017
7 Integra LifeSciences Corp. II Jun-29-2016
8 Tornier, Inc II Aug-26-2015
9 Wright Medical Technology Inc II Dec-01-2021
10 Wright Medical Technology Inc II May-07-2020
11 Wright Medical Technology, Inc. II Apr-04-2024
12 Wright Medical Technology, Inc. II Jul-07-2023
13 Wright Medical Technology, Inc. II Oct-27-2022
14 Wright Medical Technology, Inc. II Jun-27-2022
15 Wright Medical Technology, Inc. II Nov-25-2019
16 Zimmer Biomet, Inc. II Nov-07-2019
17 Zimmer, Inc. II Dec-10-2013
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