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TPLC
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Device
prosthesis, ankle, semi-constrained, cemented, metal/polymer
Product Code
HSN
Regulation Number
888.3110
Device Class
2
Premarket Reviews
Manufacturer
Decision
EXACTECH INC
SUBSTANTIALLY EQUIVALENT
1
EXACTECH INC.
SUBSTANTIALLY EQUIVALENT
1
EXACTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
IN2BONES SAS
SUBSTANTIALLY EQUIVALENT
3
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
VILEX, LLC
SUBSTANTIALLY EQUIVALENT
1
WRIGHT MEDICAL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
4
MDR Year
MDR Reports
MDR Events
2019
277
277
2020
281
281
2021
237
237
2022
453
453
2023
796
796
2024
132
132
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1131
1131
Insufficient Information
358
358
Osseointegration Problem
347
347
Migration
346
346
Loss of Osseointegration
89
89
Break
65
65
Loosening of Implant Not Related to Bone-Ingrowth
54
54
Fracture
50
50
Appropriate Term/Code Not Available
36
36
Device Dislodged or Dislocated
32
32
Loss of or Failure to Bond
27
27
Malposition of Device
26
26
Use of Device Problem
17
17
Detachment of Device or Device Component
16
16
Naturally Worn
15
15
Unintended Movement
14
14
Unstable
13
13
Device Difficult to Setup or Prepare
13
13
Patient Device Interaction Problem
12
12
Failure to Osseointegrate
11
11
Inadequacy of Device Shape and/or Size
11
11
Improper or Incorrect Procedure or Method
9
9
Defective Device
8
8
Positioning Failure
8
8
Off-Label Use
7
7
Patient-Device Incompatibility
6
6
Mechanical Jam
6
6
Component Missing
5
5
Degraded
4
4
No Apparent Adverse Event
4
4
Device Handling Problem
4
4
Positioning Problem
4
4
Inaccurate Information
3
3
Material Fragmentation
3
3
Loose or Intermittent Connection
3
3
Mechanical Problem
2
2
Nonstandard Device
2
2
Material Separation
2
2
Material Erosion
2
2
Collapse
2
2
Peeled/Delaminated
2
2
Device Markings/Labelling Problem
2
2
Device-Device Incompatibility
2
2
Material Deformation
2
2
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Compatibility Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Damaged by Another Device
1
1
Failure to Align
1
1
Unexpected Therapeutic Results
1
1
Residue After Decontamination
1
1
Difficult or Delayed Positioning
1
1
Difficult to Insert
1
1
Shipping Damage or Problem
1
1
Unsealed Device Packaging
1
1
Misassembled
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
704
704
Inadequate Osseointegration
440
440
Cyst(s)
274
274
Implant Pain
260
260
Unspecified Infection
225
225
Injury
170
170
Pain
163
163
Failure of Implant
140
140
No Clinical Signs, Symptoms or Conditions
127
127
No Code Available
121
121
Bone Fracture(s)
96
96
Swelling/ Edema
87
87
Osteolysis
77
77
Patient Problem/Medical Problem
67
67
Limb Fracture
58
58
Loss of Range of Motion
46
46
No Known Impact Or Consequence To Patient
43
43
Post Operative Wound Infection
40
40
Impaired Healing
37
37
Ossification
35
35
Wound Dehiscence
34
34
Ambulation Difficulties
31
31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
24
24
Joint Dislocation
21
21
Bacterial Infection
20
20
Discomfort
18
18
Fluid Discharge
17
17
Joint Laxity
16
16
No Information
15
15
Deformity/ Disfigurement
15
15
Numbness
14
14
Inflammation
13
13
Erythema
12
12
Fall
10
10
Tissue Damage
8
8
Unspecified Tissue Injury
8
8
Foreign Body In Patient
7
7
Osteopenia/ Osteoporosis
7
7
Purulent Discharge
7
7
Damage to Ligament(s)
6
6
Arthralgia
6
6
Arthritis
6
6
Scar Tissue
6
6
Rheumatoid Arthritis
5
5
Nerve Damage
5
5
Necrosis
4
4
Non-union Bone Fracture
4
4
Adhesion(s)
4
4
Swelling
4
4
Ankylosis
4
4
Foreign Body Reaction
4
4
Not Applicable
4
4
Subluxation
4
4
Muscular Rigidity
3
3
Thrombosis
3
3
Fatigue
3
3
Blister
3
3
Device Embedded In Tissue or Plaque
3
3
Metal Related Pathology
3
3
Joint Disorder
2
2
Debris, Bone Shedding
2
2
No Consequences Or Impact To Patient
2
2
Malunion of Bone
2
2
Sepsis
1
1
Muscle/Tendon Damage
1
1
Fibrosis
1
1
Tissue Breakdown
1
1
Burning Sensation
1
1
Seroma
1
1
Limited Mobility Of The Implanted Joint
1
1
Joint Swelling
1
1
Collapse
1
1
Rupture
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
Integra LifeSciences Corp.
II
Apr-16-2019
5
Wright Medical Technology Inc
II
Dec-01-2021
6
Wright Medical Technology Inc
II
May-07-2020
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
10
Wright Medical Technology, Inc.
II
Nov-25-2019
11
Zimmer Biomet, Inc.
II
Nov-07-2019
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