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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
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 6
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 3
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC (STRYKER)
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 281 281
2021 237 237
2022 453 453
2023 796 796
2024 1094 1094
2025 663 663

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1693 1693
Osseointegration Problem 849 849
Insufficient Information 753 753
Migration 487 487
Loss of Osseointegration 104 104
Fracture 74 74
Break 72 72
Loosening of Implant Not Related to Bone-Ingrowth 67 67
Naturally Worn 45 45
Malposition of Device 38 38
Appropriate Term/Code Not Available 35 35
Device Dislodged or Dislocated 33 33
Inadequacy of Device Shape and/or Size 31 31
Unintended Movement 22 22
Unstable 21 21
Use of Device Problem 20 20
Failure to Osseointegrate 16 16
Positioning Failure 13 13
Device Difficult to Setup or Prepare 13 13
Detachment of Device or Device Component 12 12
Biocompatibility 10 10
Patient-Device Incompatibility 10 10
Patient Device Interaction Problem 10 10
Off-Label Use 9 9
Defective Device 8 8
Component Missing 7 7
Loss of or Failure to Bond 6 6
Mechanical Jam 6 6
Inaccurate Information 6 6
Improper or Incorrect Procedure or Method 5 5
Material Deformation 5 5
Positioning Problem 4 4
Material Fragmentation 4 4
Device Handling Problem 4 4
Material Discolored 3 3
Degraded 3 3
Device Damaged by Another Device 2 2
Shipping Damage or Problem 2 2
Material Separation 2 2
No Apparent Adverse Event 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Nonstandard Device 2 2
Device Markings/Labelling Problem 2 2
Crack 2 2
Device-Device Incompatibility 2 2
Material Twisted/Bent 1 1
Failure to Align 1 1
Lack of Effect 1 1
Difficult to Insert 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1206 1206
Inadequate Osseointegration 966 966
Implant Pain 570 570
Cyst(s) 553 553
Unspecified Infection 379 379
Pain 252 252
Failure of Implant 175 175
Swelling/ Edema 159 159
No Clinical Signs, Symptoms or Conditions 158 158
Loss of Range of Motion 143 143
Osteolysis 134 134
Bone Fracture(s) 126 126
Injury 87 87
Limb Fracture 84 84
Wound Dehiscence 82 82
Ambulation Difficulties 69 69
Post Operative Wound Infection 61 61
Patient Problem/Medical Problem 57 57
Bacterial Infection 56 56
Ossification 44 44
Discomfort 42 42
Subluxation 40 40
Impaired Healing 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Joint Laxity 35 35
Deformity/ Disfigurement 26 26
Arthritis 22 22
Joint Dislocation 18 18
Numbness 18 18
Inflammation 17 17
Fluid Discharge 17 17
Nerve Damage 16 16
Erythema 15 15
Scar Tissue 14 14
No Code Available 14 14
Fall 12 12
Osteopenia/ Osteoporosis 11 11
Malunion of Bone 10 10
Fever 10 10
Necrosis 9 9
Rheumatoid Arthritis 9 9
Foreign Body Reaction 8 8
Unspecified Tissue Injury 8 8
Purulent Discharge 7 7
Foreign Body In Patient 7 7
No Information 7 7
Arthralgia 7 7
Non-union Bone Fracture 6 6
Capsular Contracture 6 6
Ankylosis 6 6

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 Wright Medical Technology Inc II Dec-01-2021
5 Wright Medical Technology Inc II May-07-2020
6 Wright Medical Technology, Inc. II Apr-04-2024
7 Wright Medical Technology, Inc. II Jul-07-2023
8 Wright Medical Technology, Inc. II Oct-27-2022
9 Wright Medical Technology, Inc. II Jun-27-2022
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