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Device
prosthesis, shoulder, hemi-, humeral, metallic uncemented
Regulation Description
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Product Code
HSD
Regulation Number
888.3690
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHREX, INC.
SUBSTANTIALLY EQUIVALENT
2
ARTHROCARE CORP.
SUBSTANTIALLY EQUIVALENT
1
ARTHROSURFACE, INC.
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST
SUBSTANTIALLY EQUIVALENT
1
ZIMMER GMBH
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
782
782
2017
985
985
2018
646
646
2019
829
829
2020
658
658
2021
114
114
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
905
905
Insufficient Information
867
867
Device Dislodged or Dislocated
692
692
Fracture
203
203
Appropriate Term/Code Not Available
201
201
Break
192
192
Loss of Osseointegration
179
179
Naturally Worn
94
94
Loose or Intermittent Connection
89
89
Migration or Expulsion of Device
81
81
Loss of or Failure to Bond
71
71
Unstable
70
70
Detachment of Device or Device Component
60
60
Difficult to Insert
57
57
Osseointegration Problem
54
54
Disassembly
51
51
Loosening of Implant Not Related to Bone-Ingrowth
50
50
Failure To Adhere Or Bond
39
39
Malposition of Device
33
33
Fitting Problem
27
27
Device Slipped
24
24
Inadequacy of Device Shape and/or Size
21
21
Migration
21
21
Device Operates Differently Than Expected
19
19
Use of Device Problem
18
18
Material Erosion
18
18
Detachment Of Device Component
17
17
Cuff
16
16
Device-Device Incompatibility
16
16
Noise, Audible
15
15
Mechanical Jam
14
14
Torn Material
14
14
Material Separation
14
14
Difficult to Remove
13
13
Patient-Device Incompatibility
13
13
Material Deformation
12
12
Positioning Problem
11
11
Connection Problem
11
11
Manufacturing, Packaging or Shipping Problem
10
10
Packaging Problem
10
10
Component Missing
10
10
Metal Shedding Debris
9
9
Failure to Osseointegrate
8
8
Device Contamination with Chemical or Other Material
8
8
Misconnection
8
8
Defective Component
7
7
Screw
7
7
Bent
6
6
Nonstandard Device
6
6
Mechanical Problem
6
6
Off-Label Use
6
6
Patient Device Interaction Problem
6
6
Failure to Advance
6
6
Unintended System Motion
5
5
Unintended Movement
5
5
Material Split, Cut or Torn
5
5
Separation Problem
5
5
Crack
5
5
Material Fragmentation
4
4
Microbial Contamination of Device
4
4
Tear, Rip or Hole in Device Packaging
4
4
Dull, Blunt
3
3
Contamination /Decontamination Problem
3
3
Misassembled
3
3
Entrapment of Device
3
3
Difficult or Delayed Positioning
3
3
Pin
3
3
Shaft
3
3
Scratched Material
3
3
Separation Failure
3
3
Defective Device
3
3
Positioning Failure
3
3
Therapeutic or Diagnostic Output Failure
3
3
Thread
2
2
Device Handling Problem
2
2
Material Twisted/Bent
2
2
Device Abrasion From Instrument Or Another Object
2
2
Material Disintegration
2
2
Degraded
2
2
Plate
2
2
Compatibility Problem
2
2
Delivered as Unsterile Product
2
2
Improper or Incorrect Procedure or Method
2
2
Device Damaged Prior to Use
1
1
Peeled/Delaminated
1
1
Material Rupture
1
1
Device Inoperable
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Failure to Disconnect
1
1
Disconnection
1
1
Guidewire
1
1
Bag
1
1
Component Falling
1
1
Contamination
1
1
Corroded
1
1
Decoupling
1
1
Incorrect Device Or Component Shipped
1
1
Issue With Displayed Error Message
1
1
Device Contaminated During Manufacture or Shipping
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
1221
1221
Pain
906
906
Unspecified Infection
742
742
No Information
672
672
Joint Dislocation
429
429
Not Applicable
218
218
No Known Impact Or Consequence To Patient
173
173
Bone Fracture(s)
159
159
No Consequences Or Impact To Patient
157
157
Inadequate Osseointegration
152
152
Loss of Range of Motion
133
133
Limited Mobility Of The Implanted Joint
99
99
Fall
81
81
Failure of Implant
73
73
Injury
70
70
Joint Disorder
68
68
Tissue Damage
61
61
Discomfort
55
55
Hematoma
54
54
Osteolysis
52
52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
51
51
Foreign Body Reaction
37
37
Death
32
32
Erosion
32
32
Patient Problem/Medical Problem
28
28
No Clinical Signs, Symptoms or Conditions
27
27
Impaired Healing
25
25
Joint Laxity
23
23
Synovitis
20
20
Device Embedded In Tissue or Plaque
19
19
Nerve Damage
18
18
Swelling
18
18
Ossification
17
17
Stroke/CVA
16
16
Insufficient Information
16
16
Muscular Rigidity
14
14
Reaction
14
14
Weakness
13
13
Adhesion(s)
13
13
No Patient Involvement
12
12
Foreign Body In Patient
11
11
Pneumonia
11
11
Inflammation
10
10
Muscle Weakness
9
9
Numbness
9
9
Osteopenia/ Osteoporosis
9
9
Fracture, Arm
8
8
Unspecified Tissue Injury
8
8
Bacterial Infection
7
7
Thrombosis
7
7
Arthritis
7
7
Staphylococcus Aureus
6
6
Rupture
6
6
Neurological Deficit/Dysfunction
5
5
Ambulation Difficulties
5
5
Cellulitis
5
5
Edema
5
5
Tingling
5
5
Pocket Erosion
4
4
Embolus
4
4
Disability
4
4
Post Operative Wound Infection
4
4
Fluid Discharge
4
4
Pulmonary Embolism
4
4
Abscess
3
3
Wound Dehiscence
3
3
Fatigue
3
3
Hypersensitivity/Allergic reaction
3
3
Excessive Tear Production
3
3
Inadequate Pain Relief
3
3
Non-union Bone Fracture
3
3
Laceration(s)
3
3
Damage to Ligament(s)
3
3
Debris, Bone Shedding
3
3
Scar Tissue
3
3
Twitching
3
3
Undesired Nerve Stimulation
2
2
Nausea
2
2
Necrosis
2
2
Arthralgia
2
2
Burning Sensation
2
2
Complaint, Ill-Defined
2
2
Thromboembolism
2
2
Fibrosis
2
2
Tissue Breakdown
2
2
Fever
2
2
Calcium Deposits/Calcification
2
2
Cognitive Changes
2
2
Neck Stiffness
2
2
Erythema
2
2
Metal Related Pathology
1
1
Muscle/Tendon Damage
1
1
Skin Tears
1
1
Cyst(s)
1
1
Dyspnea
1
1
Failure to Anastomose
1
1
Awareness during Anaesthesia
1
1
Rheumatoid Arthritis
1
1
Autoimmune Disorder
1
1
Impotence
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ascension Orthopedics, Inc
III
Feb-02-2019
2
DePuy Orthopaedics, Inc.
II
Mar-01-2018
3
Exactech, Inc.
II
Jan-22-2021
4
Fx Solutions
II
Jul-17-2018
5
Zimmer Biomet, Inc.
II
Mar-13-2018
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