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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 570 570
2022 509 509
2023 592 592
2024 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1528 1528
Device Dislodged or Dislocated 477 477
Fracture 199 199
Appropriate Term/Code Not Available 155 155
Osseointegration Problem 130 130
Break 118 118
Loss of Osseointegration 106 106
Difficult to Insert 98 98
Insufficient Information 78 78
Naturally Worn 70 70
Detachment of Device or Device Component 67 67
Loosening of Implant Not Related to Bone-Ingrowth 66 66
Loss of or Failure to Bond 58 58
Migration 37 37
Patient Device Interaction Problem 35 35
Unstable 28 28
Loose or Intermittent Connection 17 17
Device-Device Incompatibility 16 16
Malposition of Device 15 15
Use of Device Problem 15 15
Off-Label Use 15 15
Material Deformation 14 14
Noise, Audible 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Material Erosion 11 11
Packaging Problem 10 10
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
Inadequacy of Device Shape and/or Size 6 6
Fitting Problem 6 6
Device Damaged Prior to Use 6 6
Patient-Device Incompatibility 6 6
Therapeutic or Diagnostic Output Failure 6 6
Material Split, Cut or Torn 6 6
Material Twisted/Bent 5 5
Mechanical Jam 5 5
Device Markings/Labelling Problem 5 5
Difficult to Remove 5 5
Mechanical Problem 4 4
Failure to Advance 4 4
Separation Failure 3 3
Contamination /Decontamination Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Positioning Problem 3 3
Difficult or Delayed Positioning 3 3
Device Slipped 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Failure to Osseointegrate 3 3
Unexpected Therapeutic Results 2 2
Material Separation 2 2
Device Appears to Trigger Rejection 2 2
Entrapment of Device 2 2
Material Fragmentation 2 2
Nonstandard Device 2 2
Output Problem 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Dull, Blunt 2 2
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Premature Separation 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
Component Misassembled 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Decoupling 1 1
Degraded 1 1
Corroded 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Solder Joint Fracture 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 866 866
Unspecified Infection 718 718
Pain 685 685
Joint Dislocation 381 381
No Clinical Signs, Symptoms or Conditions 247 247
Inadequate Osseointegration 209 209
Joint Laxity 190 190
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Bone Fracture(s) 144 144
Loss of Range of Motion 143 143
Insufficient Information 140 140
Failure of Implant 135 135
Unspecified Tissue Injury 116 116
Not Applicable 78 78
No Consequences Or Impact To Patient 78 78
Hematoma 76 76
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 51 51
Muscular Rigidity 45 45
Osteolysis 41 41
Fall 37 37
Nerve Damage 32 32
Tissue Damage 25 25
Foreign Body Reaction 22 22
Muscle/Tendon Damage 22 22
Implant Pain 21 21
Unspecified Musculoskeletal problem 20 20
Ossification 20 20
Adhesion(s) 20 20
Stroke/CVA 19 19
Inflammation 19 19
Hypersensitivity/Allergic reaction 14 14
Bacterial Infection 14 14
Fatigue 12 12
Scar Tissue 12 12
Sepsis 11 11
No Patient Involvement 11 11
Numbness 11 11
Foreign Body In Patient 10 10
Pneumonia 10 10
Erosion 10 10
Death 9 9
Patient Problem/Medical Problem 9 9
Osteopenia/ Osteoporosis 9 9
Joint Disorder 9 9
Post Operative Wound Infection 9 9
Subluxation 9 9
Metal Related Pathology 8 8
Fluid Discharge 7 7
Pulmonary Embolism 7 7
Impaired Healing 7 7
Edema 6 6
Cyst(s) 6 6
Neurological Deficit/Dysfunction 5 5
Seroma 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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