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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
IMPLANTCAST
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 782 782
2017 985 985
2018 646 646
2019 829 829
2020 658 658
2021 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 905 905
Insufficient Information 867 867
Device Dislodged or Dislocated 692 692
Fracture 203 203
Appropriate Term/Code Not Available 201 201
Break 192 192
Loss of Osseointegration 179 179
Naturally Worn 94 94
Loose or Intermittent Connection 89 89
Migration or Expulsion of Device 81 81
Loss of or Failure to Bond 71 71
Unstable 70 70
Detachment of Device or Device Component 60 60
Difficult to Insert 57 57
Osseointegration Problem 54 54
Disassembly 51 51
Loosening of Implant Not Related to Bone-Ingrowth 50 50
Failure To Adhere Or Bond 39 39
Malposition of Device 33 33
Fitting Problem 27 27
Device Slipped 24 24
Inadequacy of Device Shape and/or Size 21 21
Migration 21 21
Device Operates Differently Than Expected 19 19
Use of Device Problem 18 18
Material Erosion 18 18
Detachment Of Device Component 17 17
Cuff 16 16
Device-Device Incompatibility 16 16
Noise, Audible 15 15
Mechanical Jam 14 14
Torn Material 14 14
Material Separation 14 14
Difficult to Remove 13 13
Patient-Device Incompatibility 13 13
Material Deformation 12 12
Positioning Problem 11 11
Connection Problem 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Packaging Problem 10 10
Component Missing 10 10
Metal Shedding Debris 9 9
Failure to Osseointegrate 8 8
Device Contamination with Chemical or Other Material 8 8
Misconnection 8 8
Defective Component 7 7
Screw 7 7
Bent 6 6
Nonstandard Device 6 6
Mechanical Problem 6 6
Off-Label Use 6 6
Patient Device Interaction Problem 6 6
Failure to Advance 6 6
Unintended System Motion 5 5
Unintended Movement 5 5
Material Split, Cut or Torn 5 5
Separation Problem 5 5
Crack 5 5
Material Fragmentation 4 4
Microbial Contamination of Device 4 4
Tear, Rip or Hole in Device Packaging 4 4
Dull, Blunt 3 3
Contamination /Decontamination Problem 3 3
Misassembled 3 3
Entrapment of Device 3 3
Difficult or Delayed Positioning 3 3
Pin 3 3
Shaft 3 3
Scratched Material 3 3
Separation Failure 3 3
Defective Device 3 3
Positioning Failure 3 3
Therapeutic or Diagnostic Output Failure 3 3
Thread 2 2
Device Handling Problem 2 2
Material Twisted/Bent 2 2
Device Abrasion From Instrument Or Another Object 2 2
Material Disintegration 2 2
Degraded 2 2
Plate 2 2
Compatibility Problem 2 2
Delivered as Unsterile Product 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 1 1
Peeled/Delaminated 1 1
Material Rupture 1 1
Device Inoperable 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Disconnect 1 1
Disconnection 1 1
Guidewire 1 1
Bag 1 1
Component Falling 1 1
Contamination 1 1
Corroded 1 1
Decoupling 1 1
Incorrect Device Or Component Shipped 1 1
Issue With Displayed Error Message 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1221 1221
Pain 906 906
Unspecified Infection 742 742
No Information 672 672
Joint Dislocation 429 429
Not Applicable 218 218
No Known Impact Or Consequence To Patient 173 173
Bone Fracture(s) 159 159
No Consequences Or Impact To Patient 157 157
Inadequate Osseointegration 152 152
Loss of Range of Motion 133 133
Limited Mobility Of The Implanted Joint 99 99
Fall 81 81
Failure of Implant 73 73
Injury 70 70
Joint Disorder 68 68
Tissue Damage 61 61
Discomfort 55 55
Hematoma 54 54
Osteolysis 52 52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Foreign Body Reaction 37 37
Death 32 32
Erosion 32 32
Patient Problem/Medical Problem 28 28
No Clinical Signs, Symptoms or Conditions 27 27
Impaired Healing 25 25
Joint Laxity 23 23
Synovitis 20 20
Device Embedded In Tissue or Plaque 19 19
Nerve Damage 18 18
Swelling 18 18
Ossification 17 17
Stroke/CVA 16 16
Insufficient Information 16 16
Muscular Rigidity 14 14
Reaction 14 14
Weakness 13 13
Adhesion(s) 13 13
No Patient Involvement 12 12
Foreign Body In Patient 11 11
Pneumonia 11 11
Inflammation 10 10
Muscle Weakness 9 9
Numbness 9 9
Osteopenia/ Osteoporosis 9 9
Fracture, Arm 8 8
Unspecified Tissue Injury 8 8
Bacterial Infection 7 7
Thrombosis 7 7
Arthritis 7 7
Staphylococcus Aureus 6 6
Rupture 6 6
Neurological Deficit/Dysfunction 5 5
Ambulation Difficulties 5 5
Cellulitis 5 5
Edema 5 5
Tingling 5 5
Pocket Erosion 4 4
Embolus 4 4
Disability 4 4
Post Operative Wound Infection 4 4
Fluid Discharge 4 4
Pulmonary Embolism 4 4
Abscess 3 3
Wound Dehiscence 3 3
Fatigue 3 3
Hypersensitivity/Allergic reaction 3 3
Excessive Tear Production 3 3
Inadequate Pain Relief 3 3
Non-union Bone Fracture 3 3
Laceration(s) 3 3
Damage to Ligament(s) 3 3
Debris, Bone Shedding 3 3
Scar Tissue 3 3
Twitching 3 3
Undesired Nerve Stimulation 2 2
Nausea 2 2
Necrosis 2 2
Arthralgia 2 2
Burning Sensation 2 2
Complaint, Ill-Defined 2 2
Thromboembolism 2 2
Fibrosis 2 2
Tissue Breakdown 2 2
Fever 2 2
Calcium Deposits/Calcification 2 2
Cognitive Changes 2 2
Neck Stiffness 2 2
Erythema 2 2
Metal Related Pathology 1 1
Muscle/Tendon Damage 1 1
Skin Tears 1 1
Cyst(s) 1 1
Dyspnea 1 1
Failure to Anastomose 1 1
Awareness during Anaesthesia 1 1
Rheumatoid Arthritis 1 1
Autoimmune Disorder 1 1
Impotence 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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