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TPLC
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Device
prosthesis, elbow, hemi-, radial, polymer
Product Code
KWI
Regulation Number
888.3170
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACUMED LLC
SUBSTANTIALLY EQUIVALENT
1
BIOPOLY, LLC
SUBSTANTIALLY EQUIVALENT
1
DEPUY SYNTHES
SUBSTANTIALLY EQUIVALENT
1
IGNITE ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME
SUBSTANTIALLY EQUIVALENT
1
IN2BONES USA, LLC
SUBSTANTIALLY EQUIVALENT
2
SKELETAL DYNAMICS INC
SUBSTANTIALLY EQUIVALENT
1
SKELETAL DYNAMICS, LLC
SUBSTANTIALLY EQUIVALENT
2
SYNTHES USA, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
29
29
2015
103
103
2016
138
138
2017
360
360
2018
202
202
2019
214
214
2020
118
118
2021
44
44
2022
44
76
2023
77
77
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
272
284
Unintended Movement
200
200
Insufficient Information
101
101
Loose or Intermittent Connection
98
107
Device Slipped
96
96
Device Dislodged or Dislocated
82
100
Detachment Of Device Component
67
67
Detachment of Device or Device Component
65
65
Migration or Expulsion of Device
55
55
Appropriate Term/Code Not Available
52
52
Loosening of Implant Not Related to Bone-Ingrowth
47
47
Material Separation
47
47
Unstable
39
39
Break
27
27
Device Operates Differently Than Expected
24
24
Migration
23
25
Inadequacy of Device Shape and/or Size
18
18
Fracture
15
15
Patient-Device Incompatibility
14
14
Mechanical Problem
13
13
Naturally Worn
12
12
Nonstandard Device
10
10
Failure To Adhere Or Bond
10
10
Component Missing
9
9
Noise, Audible
9
9
Fitting Problem
9
9
Disassembly
8
8
Inaccurate Information
7
7
Patient Device Interaction Problem
6
6
Loss of Osseointegration
6
6
Malposition of Device
6
6
Difficult to Advance
5
5
Improper or Incorrect Procedure or Method
5
5
Material Integrity Problem
4
4
Failure to Osseointegrate
4
4
Packaging Problem
4
4
Material Deformation
4
4
Component or Accessory Incompatibility
4
4
Device Packaging Compromised
3
3
Failure to Align
3
3
Positioning Problem
3
3
Metal Shedding Debris
3
3
Connection Problem
3
3
Use of Device Problem
2
2
Loss of or Failure to Bond
2
2
Osseointegration Problem
2
11
Difficult to Insert
2
2
Material Erosion
2
2
Misassembly by Users
2
2
Device Issue
2
2
Unsealed Device Packaging
2
2
Physical Resistance/Sticking
2
2
Sticking
1
1
Unintended Collision
1
1
Material Fragmentation
1
1
Material Too Rigid or Stiff
1
1
Positioning Failure
1
1
Off-Label Use
1
1
Human Factors Issue
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Rupture
1
1
Moisture Damage
1
1
Defective Device
1
1
Missing Value Reason
1
1
Device Expiration Issue
1
1
Crack
1
1
Tear, Rip or Hole in Device Packaging
1
1
Misconnection
1
1
Difficult to Remove
1
1
Expiration Date Error
1
1
Material Disintegration
1
1
Device Operational Issue
1
1
Delamination
1
1
Degraded
1
1
Misassembled
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
379
379
No Code Available
345
345
Failure of Implant
271
271
No Known Impact Or Consequence To Patient
165
165
Loss of Range of Motion
104
104
No Information
95
95
Osteolysis
53
53
Ossification
39
39
Bone Fracture(s)
38
40
Injury
36
36
Insufficient Information
33
61
Unspecified Infection
27
29
Limited Mobility Of The Implanted Joint
20
20
Joint Dislocation
19
28
Discomfort
18
18
Arthritis
15
15
Weakness
14
14
No Clinical Signs, Symptoms or Conditions
14
14
Tissue Damage
13
13
Fall
13
13
Swelling
13
13
Nerve Damage
12
12
Muscular Rigidity
11
11
Inflammation
11
11
Non-union Bone Fracture
11
11
Patient Problem/Medical Problem
11
11
Impaired Healing
10
10
No Consequences Or Impact To Patient
8
8
Implant Pain
8
8
Metal Related Pathology
7
7
Sedation
6
6
Scar Tissue
6
6
Bacterial Infection
6
6
Erosion
6
6
Fatigue
5
5
Cyst(s)
5
5
Reaction
5
5
Hypoesthesia
5
5
Joint Laxity
5
14
Unspecified Tissue Injury
5
5
Swelling/ Edema
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Fracture, Arm
4
4
Ambulation Difficulties
4
4
Inadequate Osseointegration
4
13
Osteopenia/ Osteoporosis
4
4
Irritation
4
4
Hypersensitivity/Allergic reaction
4
4
Death
3
3
Foreign Body In Patient
3
3
Toxicity
3
3
Joint Disorder
3
3
Unspecified Musculoskeletal problem
3
3
Bone Shedding Debris
2
2
Muscle/Tendon Damage
2
2
Arthralgia
2
2
Therapeutic Response, Decreased
2
2
Seroma
2
2
Device Embedded In Tissue or Plaque
2
2
Numbness
2
2
Anemia
2
2
Erythema
2
2
Calcium Deposits/Calcification
2
2
Failure to Anastomose
2
2
Wound Dehiscence
2
2
Neurological Deficit/Dysfunction
2
2
Neuropathy
2
2
Muscle Weakness
2
2
Synovitis
2
2
Sepsis
1
1
Rash
1
1
Staphylococcus Aureus
1
1
Adhesion(s)
1
1
Capsular Contracture
1
1
Ecchymosis
1
1
Foreign Body Reaction
1
1
Hemorrhage/Bleeding
1
1
Neck Stiffness
1
1
No Patient Involvement
1
1
Not Applicable
1
1
Test Result
1
1
Complaint, Ill-Defined
1
1
Rupture
1
1
Myalgia
1
1
Ankylosis
1
1
Joint Contracture
1
1
Ischemia Stroke
1
1
Unspecified Heart Problem
1
1
Renal Impairment
1
1
Subluxation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Acumed LLC
II
May-31-2017
2
Biomet, Inc.
II
May-13-2014
3
Howmedica Osteonics Corp.
II
Aug-08-2018
4
Skeletal Dynamics
II
Dec-12-2014
5
Small Bone Innovations, Inc.
II
Oct-29-2013
6
Synthes (USA) Products LLC
II
May-12-2022
7
Synthes (USA) Products LLC
II
Feb-02-2017
8
Synthes USA HQ, Inc.
II
May-03-2013
9
Wright Medical Technology Inc
II
Sep-21-2020
10
Wright Medical Technology, Inc.
II
Oct-04-2022
11
Wright Medical Technology, Inc.
II
Feb-06-2020
12
Zimmer Biomet, Inc.
II
Dec-20-2017
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