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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 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 646 646
2019 829 829
2020 658 658
2021 574 574
2022 517 517
2023 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1326 1326
Device Dislodged or Dislocated 524 524
Insufficient Information 250 250
Appropriate Term/Code Not Available 186 186
Fracture 179 179
Loss of Osseointegration 135 135
Break 119 119
Osseointegration Problem 99 99
Naturally Worn 89 89
Difficult to Insert 76 76
Loss of or Failure to Bond 71 71
Detachment of Device or Device Component 64 64
Loosening of Implant Not Related to Bone-Ingrowth 64 64
Loose or Intermittent Connection 49 49
Unstable 49 49
Migration 37 37
Migration or Expulsion of Device 24 24
Material Deformation 20 20
Patient Device Interaction Problem 19 19
Malposition of Device 18 18
Material Erosion 18 18
Device-Device Incompatibility 17 17
Use of Device Problem 16 16
Noise, Audible 14 14
Positioning Problem 13 13
Off-Label Use 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Patient-Device Incompatibility 12 12
Packaging Problem 10 10
Inadequacy of Device Shape and/or Size 10 10
Fitting Problem 10 10
Failure to Osseointegrate 9 9
Mechanical Jam 8 8
Tear, Rip or Hole in Device Packaging 7 7
Connection Problem 7 7
Failure To Adhere Or Bond 7 7
Crack 7 7
Disassembly 7 7
Therapeutic or Diagnostic Output Failure 6 6
Material Split, Cut or Torn 6 6
Separation Problem 5 5
Failure to Advance 5 5
Device Damaged Prior to Use 5 5
Difficult to Remove 5 5
Mechanical Problem 5 5
Unintended System Motion 5 5
Defective Component 4 4
Microbial Contamination of Device 4 4
Component Missing 4 4
Device Slipped 4 4
Difficult or Delayed Positioning 4 4
Positioning Failure 4 4
Unintended Movement 4 4
Material Twisted/Bent 3 3
Separation Failure 3 3
Contamination /Decontamination Problem 3 3
Difficult to Advance 3 3
Detachment Of Device Component 3 3
Material Fragmentation 3 3
Material Separation 3 3
Metal Shedding Debris 2 2
Material Disintegration 2 2
Entrapment of Device 2 2
Dull, Blunt 2 2
Device Contaminated During Manufacture or Shipping 2 2
Output Problem 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Failure to Disconnect 1 1
Compatibility Problem 1 1
Activation, Positioning or Separation Problem 1 1
Misassembled 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Corroded 1 1
Disconnection 1 1
Material Rupture 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 981 981
Pain 786 786
Unspecified Infection 694 694
Joint Dislocation 431 431
Not Applicable 214 214
Inadequate Osseointegration 198 198
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 176 176
Loss of Range of Motion 159 159
No Clinical Signs, Symptoms or Conditions 154 154
Bone Fracture(s) 145 145
Joint Laxity 139 139
No Information 122 122
No Consequences Or Impact To Patient 119 119
Failure of Implant 108 108
Insufficient Information 103 103
No Known Impact Or Consequence To Patient 84 84
Hematoma 80 80
Limited Mobility Of The Implanted Joint 73 73
Unspecified Tissue Injury 60 60
Discomfort 59 59
Injury 58 58
Fall 49 49
Osteolysis 49 49
Muscular Rigidity 44 44
Nerve Damage 38 38
Tissue Damage 36 36
Joint Disorder 32 32
Foreign Body Reaction 22 22
Ossification 22 22
Unspecified Musculoskeletal problem 20 20
Stroke/CVA 19 19
Death 19 19
Inflammation 19 19
Muscle/Tendon Damage 18 18
Erosion 15 15
Adhesion(s) 15 15
Patient Problem/Medical Problem 14 14
Numbness 13 13
Hypersensitivity/Allergic reaction 13 13
Bacterial Infection 12 12
Swelling 12 12
Foreign Body In Patient 12 12
No Patient Involvement 11 11
Sepsis 11 11
Pneumonia 10 10
Fatigue 10 10
Reaction 9 9
Osteopenia/ Osteoporosis 9 9
Impaired Healing 8 8
Post Operative Wound Infection 7 7
Fluid Discharge 7 7
Arthritis 7 7
Pocket Erosion 6 6
Scar Tissue 6 6
Ambulation Difficulties 6 6
Device Embedded In Tissue or Plaque 5 5
Implant Pain 5 5
Fracture, Arm 5 5
Neurological Deficit/Dysfunction 5 5
Pulmonary Embolism 5 5
Edema 5 5
Synovitis 4 4
Metal Related Pathology 4 4
Muscle Hypotonia 4 4
Disability 4 4
Paresthesia 3 3
Subluxation 3 3
Swelling/ Edema 3 3
Muscle Weakness 3 3
Rupture 3 3
Abscess 3 3
Debris, Bone Shedding 3 3
Arrhythmia 2 2
Wound Dehiscence 2 2
Erythema 2 2
Calcium Deposits/Calcification 2 2
Fever 2 2
Arthralgia 2 2
Weakness 2 2
Burning Sensation 2 2
Tingling 2 2
Staphylococcus Aureus 2 2
Thrombosis 2 2
Fibrosis 2 2
Tissue Breakdown 2 2
Inadequate Pain Relief 2 2
Cognitive Changes 2 2
Thromboembolism 2 2
Blood Loss 1 1
Skin Tears 1 1
Neck Stiffness 1 1
Test Result 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Limb Fracture 1 1
Peripheral Nervous Injury 1 1
Thrombus 1 1
Rash 1 1
Nausea 1 1
Necrosis 1 1
Paralysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ascension Orthopedics, Inc III Feb-02-2019
2 DePuy Orthopaedics, Inc. II Mar-01-2018
3 Exactech, Inc. II Jan-22-2021
4 Fx Solutions II Jul-17-2018
5 Zimmer Biomet, Inc. II Mar-13-2018
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