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Device
prosthesis, elbow, hemi-, radial, polymer
Regulation Description
Elbow joint radial (hemi-elbow) polymer prosthesis.
Product Code
KWI
Regulation Number
888.3170
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOPOLY, LLC
SUBSTANTIALLY EQUIVALENT
1
DEPUY SYNTHES
SUBSTANTIALLY EQUIVALENT
1
IN2BONES USA, LLC
SUBSTANTIALLY EQUIVALENT
2
SKELETAL DYNAMICS INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
118
118
2021
44
44
2022
44
76
2023
77
77
2024
124
124
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
159
171
Detachment of Device or Device Component
45
45
Device Slipped
35
35
Device Dislodged or Dislocated
32
50
Loosening of Implant Not Related to Bone-Ingrowth
31
31
Osseointegration Problem
21
39
Insufficient Information
19
27
Loose or Intermittent Connection
16
25
Appropriate Term/Code Not Available
13
13
Unstable
12
14
Migration
11
13
Inadequacy of Device Shape and/or Size
10
10
Material Separation
8
8
Inaccurate Information
7
7
Fracture
6
6
Patient Device Interaction Problem
6
6
Naturally Worn
5
5
Unintended Movement
5
5
Loss of Osseointegration
5
5
Noise, Audible
4
4
Patient-Device Incompatibility
4
4
Material Deformation
4
4
Break
3
3
Migration or Expulsion of Device
3
3
Component Missing
3
3
Separation Failure
2
2
Malposition of Device
2
2
Misassembly by Users
2
2
Packaging Problem
2
2
Positioning Failure
2
2
Moisture Damage
1
1
Fitting Problem
1
1
Use of Device Problem
1
1
Expiration Date Error
1
1
Connection Problem
1
1
Physical Resistance/Sticking
1
1
Degraded
1
1
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
102
102
Failure of Implant
63
63
Insufficient Information
45
73
Loss of Range of Motion
44
44
No Code Available
33
33
Bone Fracture(s)
25
27
Osteolysis
24
24
Inadequate Osseointegration
24
42
Unspecified Infection
19
21
Joint Laxity
18
29
Ossification
17
17
No Clinical Signs, Symptoms or Conditions
17
17
No Information
13
13
Subluxation
13
13
Implant Pain
12
12
Arthritis
11
11
Joint Dislocation
10
19
Muscular Rigidity
10
10
No Known Impact Or Consequence To Patient
9
9
Discomfort
8
8
Tissue Damage
7
7
Metal Related Pathology
7
7
Swelling/ Edema
7
7
Scar Tissue
6
6
Unspecified Tissue Injury
6
6
Weakness
5
5
Bacterial Infection
5
5
Erosion
5
5
Fatigue
5
5
Nerve Damage
4
4
Limited Mobility Of The Implanted Joint
4
4
Osteopenia/ Osteoporosis
4
4
Inflammation
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Nausea
3
3
Unspecified Musculoskeletal problem
3
3
Muscle/Tendon Damage
3
3
Bone Shedding Debris
2
2
Joint Contracture
2
2
Hypersensitivity/Allergic reaction
2
2
Anemia
2
2
Failure to Anastomose
2
2
Neurological Deficit/Dysfunction
2
2
Hypoesthesia
2
2
Injury
2
2
Swelling
2
2
Synovitis
2
2
Therapeutic Response, Decreased
2
2
Ankylosis
1
1
Infiltration into Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Synthes (USA) Products LLC
II
May-12-2022
2
Wright Medical Technology Inc
II
Sep-21-2020
3
Wright Medical Technology, Inc.
II
Oct-04-2022
4
Wright Medical Technology, Inc.
II
Feb-06-2020
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