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TPLC
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Device
prosthesis, shoulder, hemi-, humeral, metallic uncemented
Product Code
HSD
Regulation Number
888.3690
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
2
ARTHROSURFACE, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOCORE9, LLC.
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
985
985
2018
647
647
2019
829
829
2020
658
658
2021
570
570
2022
509
509
2023
592
592
2024
81
81
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1744
1744
Device Dislodged or Dislocated
745
745
Insufficient Information
623
623
Fracture
271
271
Appropriate Term/Code Not Available
251
251
Break
205
205
Loss of Osseointegration
160
160
Osseointegration Problem
138
138
Naturally Worn
115
115
Difficult to Insert
103
103
Loss of or Failure to Bond
87
87
Loosening of Implant Not Related to Bone-Ingrowth
82
82
Detachment of Device or Device Component
78
78
Unstable
65
65
Loose or Intermittent Connection
64
64
Migration or Expulsion of Device
60
60
Migration
40
40
Patient Device Interaction Problem
38
38
Disassembly
31
31
Malposition of Device
28
28
Material Deformation
24
24
Noise, Audible
22
22
Fitting Problem
21
21
Material Erosion
21
21
Device-Device Incompatibility
19
19
Failure To Adhere Or Bond
17
17
Use of Device Problem
16
16
Inadequacy of Device Shape and/or Size
15
15
Off-Label Use
15
15
Mechanical Jam
15
15
Packaging Problem
14
14
Detachment Of Device Component
14
14
Patient-Device Incompatibility
13
13
Positioning Problem
13
13
Manufacturing, Packaging or Shipping Problem
12
12
Connection Problem
10
10
Mechanical Problem
10
10
Crack
9
9
Device Slipped
9
9
Difficult to Remove
9
9
Failure to Osseointegrate
9
9
Material Separation
9
9
Inaccurate Information
9
9
Metal Shedding Debris
8
8
Component Missing
8
8
Tear, Rip or Hole in Device Packaging
8
8
Misconnection
8
8
Failure to Advance
7
7
Defective Component
7
7
Difficult to Advance
7
7
Device Operates Differently Than Expected
6
6
Material Twisted/Bent
6
6
Therapeutic or Diagnostic Output Failure
6
6
Material Split, Cut or Torn
6
6
Device Damaged Prior to Use
6
6
Positioning Failure
6
6
Bent
5
5
Unintended System Motion
5
5
Separation Problem
5
5
Unintended Movement
5
5
Device Markings/Labelling Problem
5
5
Device Contaminated During Manufacture or Shipping
4
4
Difficult or Delayed Positioning
4
4
Microbial Contamination of Device
4
4
Dull, Blunt
4
4
Separation Failure
3
3
Defective Device
3
3
Entrapment of Device
3
3
Nonstandard Device
3
3
Material Fragmentation
3
3
Contamination /Decontamination Problem
3
3
Scratched Material
3
3
No Apparent Adverse Event
2
2
Output Problem
2
2
Physical Resistance/Sticking
2
2
Device Abrasion From Instrument Or Another Object
2
2
Misassembled
2
2
Material Disintegration
2
2
Decoupling
2
2
Corroded
2
2
Improper or Incorrect Procedure or Method
2
2
Device Appears to Trigger Rejection
2
2
Unexpected Therapeutic Results
2
2
Device Inoperable
1
1
Material Rupture
1
1
Failure to Disconnect
1
1
Incomplete or Missing Packaging
1
1
Solder Joint Fracture
1
1
Contamination of Device Ingredient or Reagent
1
1
Delamination
1
1
Activation, Positioning or Separation Problem
1
1
Biocompatibility
1
1
Deformation Due to Compressive Stress
1
1
Component Falling
1
1
Contamination
1
1
Degraded
1
1
Disconnection
1
1
Incorrect Measurement
1
1
Delivered as Unsterile Product
1
1
Material Puncture/Hole
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
1092
1092
Pain
1070
1070
Unspecified Infection
993
993
Joint Dislocation
590
590
No Information
443
443
No Clinical Signs, Symptoms or Conditions
250
250
Inadequate Osseointegration
238
238
Not Applicable
215
215
Loss of Range of Motion
203
203
Bone Fracture(s)
198
198
Joint Laxity
190
190
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
174
174
Failure of Implant
162
162
Insufficient Information
142
142
No Consequences Or Impact To Patient
139
139
Unspecified Tissue Injury
118
118
No Known Impact Or Consequence To Patient
106
106
Limited Mobility Of The Implanted Joint
92
92
Hematoma
82
82
Joint Disorder
70
70
Osteolysis
64
64
Injury
64
64
Discomfort
63
63
Fall
61
61
Tissue Damage
59
59
Muscular Rigidity
47
47
Nerve Damage
44
44
Foreign Body Reaction
37
37
Erosion
34
34
Death
29
29
Ossification
26
26
Impaired Healing
24
24
Implant Pain
23
23
Muscle/Tendon Damage
22
22
Unspecified Musculoskeletal problem
22
22
Inflammation
22
22
Patient Problem/Medical Problem
21
21
Adhesion(s)
20
20
Stroke/CVA
19
19
Swelling
17
17
Numbness
17
17
Foreign Body In Patient
16
16
Synovitis
16
16
Bacterial Infection
16
16
Hypersensitivity/Allergic reaction
14
14
Fatigue
13
13
Pneumonia
13
13
Scar Tissue
12
12
Device Embedded In Tissue or Plaque
12
12
No Patient Involvement
11
11
Weakness
11
11
Sepsis
11
11
Post Operative Wound Infection
10
10
Reaction
10
10
Fluid Discharge
10
10
Subluxation
10
10
Osteopenia/ Osteoporosis
9
9
Metal Related Pathology
8
8
Thrombosis
7
7
Edema
7
7
Arthritis
7
7
Pulmonary Embolism
7
7
Cyst(s)
6
6
Muscle Weakness
6
6
Staphylococcus Aureus
6
6
Pocket Erosion
6
6
Swelling/ Edema
6
6
Ambulation Difficulties
6
6
Fracture, Arm
6
6
Tingling
5
5
Seroma
5
5
Neurological Deficit/Dysfunction
5
5
Cellulitis
5
5
Non-union Bone Fracture
4
4
Disability
4
4
Muscle Hypotonia
4
4
Thrombosis/Thrombus
4
4
Limb Fracture
3
3
Paresthesia
3
3
Unspecified Mental, Emotional or Behavioural Problem
3
3
Twitching
3
3
Rupture
3
3
Arthralgia
3
3
Inadequate Pain Relief
3
3
Abscess
3
3
Erythema
3
3
Debris, Bone Shedding
3
3
Fever
2
2
Wound Dehiscence
2
2
Angina
2
2
Arrhythmia
2
2
Calcium Deposits/Calcification
2
2
Cardiac Arrest
2
2
Undesired Nerve Stimulation
2
2
Burning Sensation
2
2
Pulmonary Edema
2
2
Complaint, Ill-Defined
2
2
Ischemic Heart Disease
2
2
Cognitive Changes
2
2
Neck Stiffness
2
2
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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