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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
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 574 574
2016 782 782
2017 985 985
2018 647 647
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 1845 1845
Device Dislodged or Dislocated 1035 1035
Insufficient Information 1031 1031
Fracture 337 337
Appropriate Term/Code Not Available 302 302
Break 281 281
Loss of Osseointegration 224 224
Loose or Intermittent Connection 139 139
Osseointegration Problem 139 139
Naturally Worn 138 138
Difficult to Insert 120 120
Loss of or Failure to Bond 102 102
Unstable 96 96
Migration or Expulsion of Device 92 92
Detachment of Device or Device Component 85 85
Loosening of Implant Not Related to Bone-Ingrowth 82 82
Disassembly 62 62
Malposition of Device 51 51
Failure To Adhere Or Bond 46 46
Migration 45 45
Device Slipped 42 42
Patient Device Interaction Problem 38 38
Device Operates Differently Than Expected 36 36
Inadequacy of Device Shape and/or Size 33 33
Fitting Problem 31 31
Detachment Of Device Component 28 28
Material Deformation 26 26
Use of Device Problem 24 24
Material Erosion 23 23
Noise, Audible 23 23
Device-Device Incompatibility 20 20
Positioning Problem 17 17
Torn Material 16 16
Material Separation 16 16
Difficult to Remove 16 16
Off-Label Use 15 15
Packaging Problem 15 15
Mechanical Jam 15 15
Connection Problem 13 13
Patient-Device Incompatibility 13 13
Mechanical Problem 13 13
Component Missing 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Failure to Osseointegrate 11 11
Tear, Rip or Hole in Device Packaging 10 10
Crack 10 10
Metal Shedding Debris 9 9
Inaccurate Information 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Contamination with Chemical or Other Material 8 8
Failure to Advance 8 8
Misconnection 8 8
Nonstandard Device 7 7
Defective Component 7 7
Difficult to Advance 7 7
Material Twisted/Bent 6 6
Material Split, Cut or Torn 6 6
Device Damaged Prior to Use 6 6
Positioning Failure 6 6
Bent 6 6
Unintended System Motion 5 5
Improper or Incorrect Procedure or Method 5 5
Separation Failure 5 5
Separation Problem 5 5
Unintended Movement 5 5
Device Markings/Labelling Problem 5 5
Device Contaminated During Manufacture or Shipping 4 4
Microbial Contamination of Device 4 4
Dull, Blunt 4 4
Material Too Rigid or Stiff 4 4
Entrapment of Device 4 4
Material Fragmentation 4 4
Difficult or Delayed Positioning 4 4
Degraded 3 3
Corroded 3 3
Misassembled 3 3
Device Appears to Trigger Rejection 3 3
Contamination /Decontamination Problem 3 3
Scratched Material 3 3
Device Inoperable 3 3
Defective Device 3 3
Compatibility Problem 3 3
Output Problem 2 2
No Apparent Adverse Event 2 2
Device Handling Problem 2 2
Component Misassembled 2 2
Physical Resistance/Sticking 2 2
Material Rupture 2 2
Unexpected Therapeutic Results 2 2
Delivered as Unsterile Product 2 2
Device Abrasion From Instrument Or Another Object 2 2
Decoupling 2 2
Material Disintegration 2 2
Disconnection 1 1
Component Falling 1 1
Component Incompatible 1 1
Contamination 1 1
Incorrect Measurement 1 1
Unsealed Device Packaging 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1393 1393
No Code Available 1364 1364
Unspecified Infection 1154 1154
No Information 820 820
Joint Dislocation 626 626
No Clinical Signs, Symptoms or Conditions 258 258
Bone Fracture(s) 256 256
Inadequate Osseointegration 239 239
Loss of Range of Motion 225 225
Not Applicable 219 219
No Known Impact Or Consequence To Patient 195 195
Joint Laxity 194 194
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Failure of Implant 174 174
No Consequences Or Impact To Patient 166 166
Insufficient Information 150 150
Unspecified Tissue Injury 128 128
Limited Mobility Of The Implanted Joint 103 103
Fall 100 100
Hematoma 85 85
Injury 76 76
Discomfort 71 71
Osteolysis 70 70
Joint Disorder 70 70
Tissue Damage 63 63
Muscular Rigidity 47 47
Nerve Damage 47 47
Foreign Body Reaction 42 42
Erosion 39 39
Patient Problem/Medical Problem 35 35
Ossification 33 33
Death 32 32
Inflammation 29 29
Device Embedded In Tissue or Plaque 29 29
Impaired Healing 26 26
Implant Pain 24 24
Muscle/Tendon Damage 23 23
Unspecified Musculoskeletal problem 22 22
Synovitis 21 21
Adhesion(s) 20 20
Bacterial Infection 19 19
Stroke/CVA 19 19
Swelling 19 19
Numbness 18 18
Pneumonia 17 17
Foreign Body In Patient 16 16
Weakness 15 15
Reaction 14 14
Hypersensitivity/Allergic reaction 14 14
Fatigue 13 13
Sepsis 12 12
Scar Tissue 12 12
Post Operative Wound Infection 12 12
No Patient Involvement 12 12
Subluxation 12 12
Fluid Discharge 11 11
Muscle Weakness 11 11
Pulmonary Embolism 11 11
Edema 10 10
Fracture, Arm 10 10
Osteopenia/ Osteoporosis 9 9
Metal Related Pathology 8 8
Rupture 8 8
Arthritis 8 8
Thrombosis 7 7
Ambulation Difficulties 7 7
Non-union Bone Fracture 6 6
Complaint, Ill-Defined 6 6
Swelling/ Edema 6 6
Staphylococcus Aureus 6 6
Pocket Erosion 6 6
Cyst(s) 6 6
Cellulitis 5 5
Wound Dehiscence 5 5
Seroma 5 5
Neurological Deficit/Dysfunction 5 5
Toxicity 5 5
Tingling 5 5
Arthralgia 4 4
Disability 4 4
Inadequate Pain Relief 4 4
Muscle Hypotonia 4 4
Thrombosis/Thrombus 4 4
Necrosis 4 4
Abscess 4 4
Embolus 4 4
Erythema 4 4
Debris, Bone Shedding 3 3
Pulmonary Edema 3 3
Laceration(s) 3 3
Damage to Ligament(s) 3 3
Paresthesia 3 3
Unspecified Mental, Emotional or Behavioural Problem 3 3
Limb Fracture 3 3
Test Result 3 3
Excessive Tear Production 3 3
Twitching 3 3
Burning Sensation 2 2
Joint Swelling 2 2
Cognitive Changes 2 2

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 Exactech, Inc. II Jan-22-2021
5 Fx Solutions II Jul-17-2018
6 Limacorporate S.p.A II Sep-02-2015
7 Zimmer Biomet, Inc. II Mar-13-2018
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