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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
Regulation Description Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Product CodeHSD
Regulation Number 888.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 574 574
2016 782 782
2017 984 984
2018 646 646
2019 829 829
2020 512 512

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1012 1012
Adverse Event Without Identified Device or Use Problem 823 823
Device Dislodged or Dislocated 767 767
Appropriate Term/Code Not Available 214 214
Loss of Osseointegration 213 213
Fracture 211 211
Break 206 206
Loose or Intermittent Connection 130 130
Naturally Worn 97 97
Migration or Expulsion of Device 91 91
Unstable 76 76
Loss of or Failure to Bond 72 72
Disassembly 62 62
Detachment of Device or Device Component 56 56
Difficult to Insert 53 53
Failure To Adhere Or Bond 46 46
Malposition of Device 46 46
Loosening of Implant Not Related to Bone-Ingrowth 45 45
Device Slipped 42 42
Device Operates Differently Than Expected 36 36
Osseointegration Problem 33 33
Fitting Problem 30 30
Inadequacy of Device Shape and/or Size 29 29
Detachment Of Device Component 28 28
Material Erosion 19 19
Migration 19 19
Use of Device Problem 18 18
Cuff 17 17
Device-Device Incompatibility 16 16
Material Separation 16 16
Torn Material 16 16
Noise, Audible 16 16
Mechanical Jam 14 14
Screw 14 14
Difficult to Remove 13 13
Positioning Problem 13 13
Connection Problem 12 12
Material Deformation 12 12
Patient-Device Incompatibility 12 12
Component Missing 11 11
Failure to Osseointegrate 10 10
Packaging Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Metal Shedding Debris 9 9
Mechanical Problem 8 8
Device Contamination with Chemical or Other Material 8 8
Misconnection 8 8
Defective Component 7 7
Failure to Advance 6 6
Plate 6 6
Bent 6 6
Nonstandard Device 6 6
Therapeutic or Diagnostic Output Failure 5 5
Separation Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Unintended System Motion 5 5
Improper or Incorrect Procedure or Method 5 5
Shaft 4 4
Unintended Movement 4 4
Patient Device Interaction Problem 4 4
Thread 4 4
Material Fragmentation 4 4
Crack 4 4
Off-Label Use 4 4
Material Too Rigid or Stiff 4 4
Microbial Contamination of Device 4 4
Separation Failure 3 3
Material Split, Cut or Torn 3 3
Defective Device 3 3
Scratched Material 3 3
Compatibility Problem 3 3
Entrapment of Device 3 3
Difficult or Delayed Positioning 3 3
Misassembled 3 3
Pin 3 3
Device Inoperable 3 3
Dull, Blunt 3 3
Contamination /Decontamination Problem 2 2
Delivered as Unsterile Product 2 2
Material Rupture 2 2
Device Handling Problem 2 2
Device Abrasion From Instrument Or Another Object 2 2
Degraded 2 2
Positioning Failure 2 2
Material Disintegration 2 2
Incorrect Measurement 1 1
Particulates 1 1
Pitted 1 1
Difficult To Position 1 1
Component Incompatible 1 1
Seal 1 1
Material Puncture/Hole 1 1
Failure to Form Staple 1 1
Incomplete or Missing Packaging 1 1
Failure to Align 1 1
Split 1 1
Tip 1 1
Deformation Due to Compressive Stress 1 1
Delamination 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1317 1317
Pain 991 991
No Information 814 814
Unspecified Infection 760 760
Joint Dislocation 413 413
Not Applicable 217 217
No Known Impact Or Consequence To Patient 191 191
Bone Fracture(s) 168 168
No Consequences Or Impact To Patient 164 164
Inadequate Osseointegration 123 123
Loss of Range of Motion 113 113
Limited Mobility Of The Implanted Joint 99 99
Fall 79 79
Failure of Implant 73 73
Injury 71 71
Joint Disorder 68 68
Tissue Damage 58 58
Hematoma 56 56
Osteolysis 50 50
Discomfort 49 49
Patient Problem/Medical Problem 35 35
Death 32 32
Erosion 31 31
Foreign Body Reaction 27 27
Device Embedded In Tissue or Plaque 27 27
Impaired Healing 24 24
Synovitis 21 21
Swelling 19 19
Nerve Damage 18 18
Ossification 17 17
Stroke/CVA 16 16
Weakness 13 13
Reaction 13 13
Inflammation 12 12
No Patient Involvement 11 11
Muscular Rigidity 11 11
Foreign Body In Patient 10 10
Fracture, Arm 10 10
Muscle Weakness 9 9
Osteopenia/ Osteoporosis 9 9
Numbness 8 8
Edema 8 8
Bacterial Infection 7 7
Thrombosis 7 7
Arthritis 7 7
Rupture 6 6
Adhesion(s) 6 6
Complaint, Ill-Defined 6 6
Tingling 5 5
Cellulitis 5 5
Staphylococcus Aureus 5 5
Neurological Deficit/Dysfunction 5 5
Ambulation Difficulties 5 5
Toxicity 5 5
Fluid Discharge 4 4
Pulmonary Embolism 4 4
Abscess 4 4
Embolus 4 4
Necrosis 4 4
Pocket Erosion 4 4
Post Operative Wound Infection 4 4
Inadequate Pain Relief 4 4
Non-union Bone Fracture 4 4
Disability 4 4
Twitching 3 3
Test Result 3 3
Pneumonia 3 3
Laceration(s) 3 3
Debris, Bone Shedding 3 3
Wound Dehiscence 3 3
Hypersensitivity/Allergic reaction 3 3
Excessive Tear Production 3 3
Sepsis 2 2
Erythema 2 2
Fever 2 2
Rheumatoid Arthritis 2 2
Calcium Deposits/Calcification 2 2
Cognitive Changes 2 2
Neck Stiffness 2 2
Cancer 2 2
Damage to Ligament(s) 2 2
Eye Injury 2 2
Scar Tissue 2 2
Burning Sensation 2 2
Nausea 2 2
Undesired Nerve Stimulation 2 2
Tissue Breakdown 2 2
Arthralgia 2 2
Joint Swelling 2 2
Thromboembolism 2 2
Blood Loss 1 1
Heart Failure 1 1
Anxiety 1 1
Fibrosis 1 1
Pulmonary Edema 1 1
Paralysis 1 1
Vomiting 1 1
Scarring 1 1
Myocardial Infarction 1 1
Atrial Fibrillation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrosurface, Inc. II Feb-12-2015
2 Ascension Orthopedics, Inc III Feb-02-2019
3 DePuy Orthopaedics, Inc. II Mar-01-2018
4 Fx Solutions II Jul-17-2018
5 Limacorporate S.p.A II Sep-02-2015
6 Zimmer Biomet, Inc. II Mar-13-2018
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