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TPLC
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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
BIOCORE9, LLC.
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
657
657
2021
573
573
2022
508
508
2023
592
592
2024
701
701
2025
64
64
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1543
1543
Device Dislodged or Dislocated
410
410
Fracture
209
209
Osseointegration Problem
156
156
Appropriate Term/Code Not Available
133
133
Break
120
120
Difficult to Insert
104
104
Loosening of Implant Not Related to Bone-Ingrowth
73
73
Detachment of Device or Device Component
68
68
Naturally Worn
61
61
Loss of or Failure to Bond
57
57
Patient Device Interaction Problem
56
56
Loss of Osseointegration
45
45
Migration
40
40
Insufficient Information
35
35
Unstable
32
32
Material Deformation
15
15
Use of Device Problem
14
14
Device-Device Incompatibility
13
13
Manufacturing, Packaging or Shipping Problem
12
12
Off-Label Use
12
12
Loose or Intermittent Connection
12
12
Positioning Failure
12
12
Device Damaged Prior to Use
11
11
Tear, Rip or Hole in Device Packaging
10
10
Noise, Audible
10
10
Inaccurate Information
9
9
Malposition of Device
9
9
Crack
9
9
Difficult to Advance
8
8
Material Twisted/Bent
6
6
Packaging Problem
6
6
Material Erosion
6
6
Material Split, Cut or Torn
6
6
Inadequacy of Device Shape and/or Size
5
5
Positioning Problem
5
5
Device Appears to Trigger Rejection
5
5
Therapeutic or Diagnostic Output Failure
5
5
Device Markings/Labelling Problem
5
5
Degraded
5
5
Mechanical Problem
5
5
Failure to Advance
4
4
Component Misassembled
3
3
Patient-Device Incompatibility
3
3
No Apparent Adverse Event
3
3
Fitting Problem
3
3
Connection Problem
3
3
Separation Failure
3
3
Corroded
3
3
Difficult to Remove
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
668
668
Pain
614
614
No Code Available
334
334
Joint Dislocation
323
323
No Clinical Signs, Symptoms or Conditions
310
310
Joint Laxity
249
249
Insufficient Information
219
219
Inadequate Osseointegration
200
200
Failure of Implant
175
175
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
174
174
Unspecified Tissue Injury
174
174
Bone Fracture(s)
142
142
Loss of Range of Motion
133
133
Muscular Rigidity
41
41
Fall
39
39
Hematoma
38
38
No Information
35
35
No Known Impact Or Consequence To Patient
34
34
Osteolysis
33
33
Nerve Damage
32
32
Implant Pain
32
32
Limited Mobility Of The Implanted Joint
31
31
No Consequences Or Impact To Patient
30
30
Discomfort
30
30
Muscle/Tendon Damage
27
27
Foreign Body Reaction
25
25
Ossification
22
22
Inflammation
22
22
Unspecified Musculoskeletal problem
22
22
Adhesion(s)
19
19
Bacterial Infection
16
16
Hypersensitivity/Allergic reaction
15
15
Metal Related Pathology
14
14
Not Applicable
14
14
Pneumonia
14
14
Fatigue
13
13
Erosion
12
12
Injury
12
12
Tissue Damage
12
12
Subluxation
12
12
Sepsis
11
11
Foreign Body In Patient
10
10
Scar Tissue
10
10
Numbness
10
10
Pulmonary Embolism
9
9
Post Operative Wound Infection
8
8
Non-union Bone Fracture
7
7
No Patient Involvement
7
7
Fluid Discharge
7
7
Neuropathy
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Exactech, Inc.
II
Jan-22-2021
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