Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 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 5
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 2
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 525 525

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1417 1417
Insufficient Information 576 576
Osseointegration Problem 512 512
Migration 433 433
Loss of Osseointegration 156 156
Break 90 90
Fracture 73 73
Appropriate Term/Code Not Available 63 63
Loosening of Implant Not Related to Bone-Ingrowth 61 61
Naturally Worn 55 55
Migration or Expulsion of Device 51 51
Device Dislodged or Dislocated 45 45
Malposition of Device 39 39
Loss of or Failure to Bond 28 28
Use of Device Problem 26 26
Unstable 19 19
Loose or Intermittent Connection 19 19
Detachment of Device or Device Component 17 17
Unintended Movement 16 16
Improper or Incorrect Procedure or Method 16 16
Failure to Osseointegrate 16 16
Device Operates Differently Than Expected 14 14
Inadequacy of Device Shape and/or Size 14 14
Device Difficult to Setup or Prepare 14 14
Disassembly 13 13
Patient-Device Incompatibility 12 12
Patient Device Interaction Problem 12 12
Mechanical Jam 11 11
Device Inoperable 10 10
Positioning Problem 9 9
Positioning Failure 9 9
Failure To Adhere Or Bond 8 8
Defective Device 8 8
Mechanical Problem 8 8
Off-Label Use 8 8
Device Slipped 8 8
Component Missing 6 6
Inaccurate Information 5 5
Material Deformation 5 5
Noise, Audible 5 5
Collapse 5 5
No Apparent Adverse Event 5 5
Degraded 4 4
Device Handling Problem 4 4
Material Fragmentation 3 3
Radiation Overexposure 3 3
Device Markings/Labelling Problem 3 3
Difficult To Position 3 3
Detachment Of Device Component 3 3
Material Erosion 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 853 853
Inadequate Osseointegration 640 640
Cyst(s) 418 418
Implant Pain 367 367
Unspecified Infection 329 329
Pain 295 295
No Code Available 202 202
Injury 181 181
Failure of Implant 168 168
Bone Fracture(s) 143 143
No Clinical Signs, Symptoms or Conditions 141 141
No Known Impact Or Consequence To Patient 126 126
Osteolysis 117 117
Swelling/ Edema 101 101
Patient Problem/Medical Problem 92 92
Loss of Range of Motion 85 85
Limb Fracture 73 73
No Information 71 71
Impaired Healing 58 58
Post Operative Wound Infection 53 53
Ossification 50 50
Ambulation Difficulties 44 44
Wound Dehiscence 38 38
Discomfort 33 33
Swelling 31 31
Bacterial Infection 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Joint Dislocation 27 27
Arthritis 27 27
Deformity/ Disfigurement 22 22
Joint Laxity 19 19
Fluid Discharge 18 18
Osteopenia/ Osteoporosis 17 17
Limited Mobility Of The Implanted Joint 15 15
Inflammation 15 15
Fall 14 14
Numbness 14 14
Erythema 14 14
Tissue Damage 11 11
Necrosis 9 9
Anxiety 9 9
Rheumatoid Arthritis 9 9
Depression 9 9
Joint Disorder 8 8
Unspecified Tissue Injury 8 8
Foreign Body In Patient 8 8
Not Applicable 7 7
Inadequate Pain Relief 7 7
Arthralgia 7 7
Non-union Bone Fracture 7 7

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
-
-