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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 231 231

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1652 1652
Device Dislodged or Dislocated 494 494
Fracture 215 215
Appropriate Term/Code Not Available 159 159
Osseointegration Problem 140 140
Break 123 123
Loss of Osseointegration 106 106
Difficult to Insert 103 103
Insufficient Information 79 79
Naturally Worn 76 76
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 38 38
Unstable 30 30
Use of Device Problem 18 18
Loose or Intermittent Connection 17 17
Material Deformation 17 17
Device-Device Incompatibility 17 17
Malposition of Device 15 15
Off-Label Use 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
Patient-Device Incompatibility 6 6
Fitting Problem 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
Mechanical Problem 5 5
Difficult to Remove 5 5
Device Appears to Trigger Rejection 3 3
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
Device Contaminated During Manufacture or Shipping 3 3
Separation Failure 3 3
Dull, Blunt 2 2
Output Problem 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Component Misassembled 2 2
Entrapment of Device 2 2
Material Fragmentation 2 2
Nonstandard Device 2 2
Unexpected Therapeutic Results 2 2
Material Separation 2 2
Physical Resistance/Sticking 2 2
Separation Problem 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
Degraded 1 1
Failure to Disconnect 1 1
Defective Device 1 1
Biocompatibility 1 1
Connection Problem 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 778 778
Pain 720 720
Joint Dislocation 394 394
No Clinical Signs, Symptoms or Conditions 266 266
Inadequate Osseointegration 219 219
Joint Laxity 199 199
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Insufficient Information 158 158
Bone Fracture(s) 157 157
Loss of Range of Motion 151 151
Failure of Implant 146 146
Unspecified Tissue Injury 129 129
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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