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TPLC
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Device
prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Description
Ankle joint metal/polymer semi-constrained cemented prosthesis.
Product Code
HSN
Regulation Number
888.3110
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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