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TPLC
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show TPLC since
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Device
prosthesis, elbow, hemi-, radial, polymer
Product Code
KWI
Regulation Number
888.3170
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY SYNTHES
SUBSTANTIALLY EQUIVALENT
1
IGNITE ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
IN2BONES USA, LLC
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
202
202
2019
214
214
2020
118
118
2021
44
44
2022
44
76
2023
39
39
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
191
203
Device Slipped
75
75
Unintended Movement
52
52
Loose or Intermittent Connection
50
59
Detachment of Device or Device Component
46
46
Loosening of Implant Not Related to Bone-Ingrowth
44
44
Appropriate Term/Code Not Available
43
43
Insufficient Information
38
38
Device Dislodged or Dislocated
37
46
Migration
22
24
Material Separation
21
21
Mechanical Problem
12
12
Inadequacy of Device Shape and/or Size
11
11
Nonstandard Device
10
10
Fracture
9
9
Patient-Device Incompatibility
8
8
Device Operates Differently Than Expected
7
7
Break
7
7
Noise, Audible
7
7
Naturally Worn
6
6
Migration or Expulsion of Device
5
5
Unstable
4
4
Loss of Osseointegration
4
4
Failure to Osseointegrate
4
4
Inaccurate Information
4
4
Detachment Of Device Component
3
3
Use of Device Problem
2
2
Failure To Adhere Or Bond
2
2
Component Missing
2
2
Material Deformation
2
2
Material Integrity Problem
2
2
Misassembly by Users
2
2
Patient Device Interaction Problem
2
2
Physical Resistance/Sticking
2
2
Packaging Problem
1
1
Positioning Problem
1
1
Device Operational Issue
1
1
Human Factors Issue
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Defective Device
1
1
Connection Problem
1
1
Difficult to Insert
1
1
Material Too Rigid or Stiff
1
1
Crack
1
1
Positioning Failure
1
1
Moisture Damage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
206
206
No Code Available
160
160
Failure of Implant
89
89
Loss of Range of Motion
70
70
No Known Impact Or Consequence To Patient
67
67
No Information
56
56
Osteolysis
41
41
Ossification
33
33
Injury
32
32
Bone Fracture(s)
27
29
Insufficient Information
26
54
No Clinical Signs, Symptoms or Conditions
11
11
Weakness
11
11
Unspecified Infection
10
12
Muscular Rigidity
10
10
Nerve Damage
10
10
Arthritis
10
10
Joint Dislocation
10
10
Discomfort
9
9
Patient Problem/Medical Problem
8
8
Swelling
8
8
Tissue Damage
7
7
Limited Mobility Of The Implanted Joint
7
7
Implant Pain
7
7
Hypoesthesia
5
5
Inflammation
5
5
Bacterial Infection
5
5
Fatigue
5
5
Scar Tissue
4
4
Impaired Healing
4
4
Ambulation Difficulties
4
4
Unspecified Tissue Injury
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Joint Laxity
3
3
Inadequate Osseointegration
3
3
Cyst(s)
3
3
Death
3
3
Erythema
2
2
Anemia
2
2
Hypersensitivity/Allergic reaction
2
2
Erosion
2
2
Calcium Deposits/Calcification
2
2
Failure to Anastomose
2
2
Wound Dehiscence
2
2
Neurological Deficit/Dysfunction
2
2
Neuropathy
2
2
Synovitis
2
2
Therapeutic Response, Decreased
2
2
Osteopenia/ Osteoporosis
2
2
Reaction
2
2
Joint Disorder
2
2
Fracture, Arm
2
2
Muscle/Tendon Damage
2
2
Swelling/ Edema
2
2
Bone Shedding Debris
2
2
Unspecified Musculoskeletal problem
1
1
Joint Contracture
1
1
Ischemia Stroke
1
1
Unspecified Heart Problem
1
1
Renal Impairment
1
1
Subluxation
1
1
Complaint, Ill-Defined
1
1
Foreign Body In Patient
1
1
Not Applicable
1
1
No Consequences Or Impact To Patient
1
1
Myalgia
1
1
Sepsis
1
1
Adhesion(s)
1
1
Hemorrhage/Bleeding
1
1
Foreign Body Reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Aug-08-2018
2
Synthes (USA) Products LLC
II
May-12-2022
3
Wright Medical Technology Inc
II
Sep-21-2020
4
Wright Medical Technology, Inc.
II
Oct-04-2022
5
Wright Medical Technology, Inc.
II
Feb-06-2020
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