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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, shoulder, hemi-, humeral, metallic uncemented
Product CodeHSD
Regulation Number 888.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 829 829
2020 658 658
2021 574 574
2022 509 509
2023 592 592
2024 405 405

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1741 1741
Device Dislodged or Dislocated 521 521
Fracture 221 221
Osseointegration Problem 159 159
Appropriate Term/Code Not Available 159 159
Break 127 127
Loss of Osseointegration 106 106
Difficult to Insert 105 105
Insufficient Information 80 80
Naturally Worn 77 77
Loosening of Implant Not Related to Bone-Ingrowth 74 74
Detachment of Device or Device Component 72 72
Loss of or Failure to Bond 70 70
Patient Device Interaction Problem 44 44
Migration 43 43
Unstable 35 35
Use of Device Problem 18 18
Device-Device Incompatibility 18 18
Material Deformation 17 17
Loose or Intermittent Connection 17 17
Off-Label Use 15 15
Malposition of Device 15 15
Noise, Audible 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Material Erosion 11 11
Packaging Problem 10 10
Inadequacy of Device Shape and/or Size 9 9
Inaccurate Information 9 9
Tear, Rip or Hole in Device Packaging 8 8
Difficult to Advance 8 8
Fitting Problem 7 7
Device Damaged Prior to Use 7 7
Positioning Failure 7 7
Crack 7 7
Migration or Expulsion of Device 6 6
Patient-Device Incompatibility 6 6
Material Twisted/Bent 6 6
Therapeutic or Diagnostic Output Failure 6 6
Material Split, Cut or Torn 6 6
Mechanical Jam 5 5
Positioning Problem 5 5
Failure to Advance 5 5
Device Markings/Labelling Problem 5 5
Difficult to Remove 5 5
Mechanical Problem 5 5
Device Appears to Trigger Rejection 4 4
Device Slipped 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Failure to Osseointegrate 3 3
Difficult or Delayed Positioning 3 3
Corroded 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Separation Failure 3 3
No Apparent Adverse Event 3 3
Unintended Movement 2 2
Output Problem 2 2
Material Separation 2 2
Defective Device 2 2
Dull, Blunt 2 2
Entrapment of Device 2 2
Degraded 2 2
Material Fragmentation 2 2
Nonstandard Device 2 2
Unexpected Therapeutic Results 2 2
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Component Misassembled 2 2
Premature Separation 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Solder Joint Fracture 1 1
Defective Component 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Decoupling 1 1
Failure to Disconnect 1 1
Biocompatibility 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 866 866
Unspecified Infection 860 860
Pain 735 735
Joint Dislocation 414 414
No Clinical Signs, Symptoms or Conditions 274 274
Inadequate Osseointegration 238 238
Joint Laxity 214 214
Insufficient Information 184 184
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 175 175
Bone Fracture(s) 173 173
Failure of Implant 156 156
Loss of Range of Motion 151 151
Unspecified Tissue Injury 142 142
Hematoma 81 81
No Consequences Or Impact To Patient 78 78
Not Applicable 78 78
No Information 75 75
No Known Impact Or Consequence To Patient 67 67
Limited Mobility Of The Implanted Joint 56 56
Injury 54 54
Discomfort 52 52
Muscular Rigidity 45 45
Osteolysis 43 43
Fall 40 40
Nerve Damage 35 35
Foreign Body Reaction 29 29
Implant Pain 26 26
Tissue Damage 25 25
Ossification 24 24
Muscle/Tendon Damage 24 24
Unspecified Musculoskeletal problem 22 22
Adhesion(s) 20 20
Inflammation 20 20
Stroke/CVA 19 19
Bacterial Infection 18 18
Hypersensitivity/Allergic reaction 17 17
Pneumonia 14 14
Scar Tissue 12 12
Erosion 12 12
Fatigue 12 12
Subluxation 12 12
Numbness 12 12
Foreign Body In Patient 11 11
No Patient Involvement 11 11
Pulmonary Embolism 11 11
Sepsis 11 11
Death 9 9
Osteopenia/ Osteoporosis 9 9
Patient Problem/Medical Problem 9 9
Post Operative Wound Infection 9 9
Joint Disorder 9 9
Metal Related Pathology 9 9
Fluid Discharge 7 7
Impaired Healing 7 7
Edema 6 6
Cyst(s) 6 6
Swelling/ Edema 6 6
Reaction 5 5
Non-union Bone Fracture 5 5
Rheumatoid Arthritis 5 5
Synovitis 5 5
Seroma 5 5
Neurological Deficit/Dysfunction 5 5
Paralysis 4 4
Swelling 4 4
Fracture, Arm 4 4
Disability 4 4
Muscle Hypotonia 4 4
Thrombosis/Thrombus 4 4
Paresthesia 3 3
Unspecified Mental, Emotional or Behavioural Problem 3 3
Limb Fracture 3 3
Device Embedded In Tissue or Plaque 3 3
Ambulation Difficulties 3 3
Arthralgia 3 3
Perforation of Vessels 3 3
Weakness 3 3
Rupture 3 3
Abscess 3 3
Hemorrhage/Bleeding 3 3
Debris, Bone Shedding 3 3
Erythema 2 2
Fever 2 2
Wound Dehiscence 2 2
Angina 2 2
Arrhythmia 2 2
Arthritis 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Thrombosis 2 2
Pocket Erosion 2 2
Pulmonary Edema 2 2
Staphylococcus Aureus 2 2
Muscle Weakness 2 2
Thromboembolism 2 2
Ischemic Heart Disease 2 2
Fibrosis 2 2
Heart Failure/Congestive Heart Failure 2 2
Test Result 1 1
Peripheral Nervous Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ascension Orthopedics, Inc III Feb-02-2019
2 Exactech, Inc. II Jan-22-2021
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