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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 267 267

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1664 1664
Device Dislodged or Dislocated 500 500
Fracture 218 218
Appropriate Term/Code Not Available 159 159
Osseointegration Problem 145 145
Break 125 125
Loss of Osseointegration 106 106
Difficult to Insert 103 103
Insufficient Information 79 79
Naturally Worn 77 77
Detachment of Device or Device Component 71 71
Loosening of Implant Not Related to Bone-Ingrowth 67 67
Loss of or Failure to Bond 58 58
Migration 42 42
Patient Device Interaction Problem 40 40
Unstable 30 30
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 7 7
Device Damaged Prior to Use 7 7
Crack 7 7
Positioning Failure 6 6
Migration or Expulsion of Device 6 6
Fitting Problem 6 6
Patient-Device Incompatibility 6 6
Therapeutic or Diagnostic Output Failure 6 6
Material Twisted/Bent 6 6
Material Split, Cut or Torn 6 6
Mechanical Jam 5 5
Positioning Problem 5 5
Device Markings/Labelling Problem 5 5
Failure to Advance 5 5
Difficult to Remove 5 5
Mechanical Problem 5 5
Device Appears to Trigger Rejection 4 4
Device Slipped 3 3
Failure to Osseointegrate 3 3
Difficult or Delayed Positioning 3 3
Corroded 3 3
Separation Failure 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
No Apparent Adverse Event 3 3
Device Contaminated During Manufacture or Shipping 3 3
Output Problem 2 2
Unintended Movement 2 2
Dull, Blunt 2 2
Defective Device 2 2
Entrapment of Device 2 2
Degraded 2 2
Material Fragmentation 2 2
Nonstandard Device 2 2
Material Separation 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
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Decoupling 1 1
Failure to Disconnect 1 1
Solder Joint Fracture 1 1
Activation, Positioning or Separation Problem 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 866 866
Unspecified Infection 788 788
Pain 722 722
Joint Dislocation 400 400
No Clinical Signs, Symptoms or Conditions 270 270
Inadequate Osseointegration 224 224
Joint Laxity 200 200
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Insufficient Information 165 165
Bone Fracture(s) 157 157
Loss of Range of Motion 151 151
Failure of Implant 148 148
Unspecified Tissue Injury 132 132
Not Applicable 78 78
No Consequences Or Impact To Patient 78 78
Hematoma 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 32 32
Foreign Body Reaction 26 26
Implant Pain 26 26
Tissue Damage 25 25
Muscle/Tendon Damage 23 23
Unspecified Musculoskeletal problem 22 22
Ossification 21 21
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
Fatigue 12 12
Erosion 12 12
Numbness 12 12
Subluxation 12 12
No Patient Involvement 11 11
Foreign Body In Patient 11 11
Pulmonary Embolism 11 11
Sepsis 11 11
Death 9 9
Patient Problem/Medical Problem 9 9
Osteopenia/ Osteoporosis 9 9
Joint Disorder 9 9
Post Operative Wound Infection 9 9
Metal Related Pathology 8 8
Fluid Discharge 7 7
Impaired Healing 7 7
Edema 6 6
Cyst(s) 6 6
Swelling/ Edema 6 6
Reaction 5 5
Rheumatoid Arthritis 5 5
Seroma 5 5
Synovitis 5 5
Neurological Deficit/Dysfunction 5 5
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
Rupture 3 3
Weakness 3 3
Non-union Bone Fracture 3 3
Arthralgia 3 3
Abscess 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
Muscle Weakness 2 2
Thrombosis 2 2
Staphylococcus Aureus 2 2
Pocket Erosion 2 2
Pulmonary Edema 2 2
Ischemic Heart Disease 2 2
Thromboembolism 2 2
Fibrosis 2 2
Heart Failure/Congestive Heart Failure 2 2
Test Result 1 1
Peripheral Nervous Injury 1 1
Tissue Breakdown 1 1
Skin Tears 1 1
Fungal Infection 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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