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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 570 570
2022 509 509
2023 592 592
2024 154 154

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1605 1605
Device Dislodged or Dislocated 485 485
Fracture 209 209
Appropriate Term/Code Not Available 155 155
Osseointegration Problem 130 130
Break 122 122
Loss of Osseointegration 106 106
Difficult to Insert 100 100
Insufficient Information 78 78
Naturally Worn 75 75
Detachment of Device or Device Component 69 69
Loosening of Implant Not Related to Bone-Ingrowth 66 66
Loss of or Failure to Bond 58 58
Migration 42 42
Patient Device Interaction Problem 38 38
Unstable 28 28
Loose or Intermittent Connection 17 17
Material Deformation 17 17
Device-Device Incompatibility 16 16
Use of Device Problem 16 16
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
Crack 7 7
Positioning Failure 6 6
Migration or Expulsion of Device 6 6
Fitting Problem 6 6
Device Damaged Prior to Use 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
Difficult or Delayed Positioning 3 3
Corroded 3 3
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
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
Unexpected Therapeutic Results 2 2
Material Separation 2 2
Entrapment of Device 2 2
Material Fragmentation 2 2
Nonstandard Device 2 2
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Premature Separation 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Decoupling 1 1
Degraded 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Solder Joint Fracture 1 1
Defective Component 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 748 748
Pain 710 710
Joint Dislocation 389 389
No Clinical Signs, Symptoms or Conditions 258 258
Inadequate Osseointegration 209 209
Joint Laxity 194 194
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Bone Fracture(s) 154 154
Loss of Range of Motion 151 151
Insufficient Information 150 150
Failure of Implant 140 140
Unspecified Tissue Injury 127 127
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
Tissue Damage 25 25
Implant Pain 24 24
Muscle/Tendon Damage 23 23
Unspecified Musculoskeletal problem 22 22
Foreign Body Reaction 22 22
Ossification 20 20
Adhesion(s) 20 20
Stroke/CVA 19 19
Inflammation 19 19
Bacterial Infection 16 16
Hypersensitivity/Allergic reaction 14 14
Pneumonia 14 14
Scar Tissue 12 12
Fatigue 12 12
Numbness 12 12
Subluxation 12 12
No Patient Involvement 11 11
Foreign Body In Patient 11 11
Erosion 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
Seroma 5 5
Neurological Deficit/Dysfunction 5 5
Reaction 5 5
Swelling/ Edema 5 5
Disability 4 4
Muscle Hypotonia 4 4
Thrombosis/Thrombus 4 4
Swelling 4 4
Synovitis 4 4
Fracture, Arm 4 4
Rupture 3 3
Weakness 3 3
Arthralgia 3 3
Debris, Bone Shedding 3 3
Abscess 3 3
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
Ischemic Heart Disease 2 2
Thromboembolism 2 2
Fibrosis 2 2
Heart Failure/Congestive Heart Failure 2 2
Wound Dehiscence 2 2
Angina 2 2
Arrhythmia 2 2
Arthritis 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Erythema 2 2
Non-union Bone Fracture 2 2
Muscle Weakness 2 2
Thrombosis 2 2
Staphylococcus Aureus 2 2
Pocket Erosion 2 2
Pulmonary Edema 2 2
Paralysis 1 1
Impotence 1 1
Scarring 1 1
Thrombus 1 1
Hypoesthesia 1 1
Heart Failure 1 1
Joint Swelling 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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