• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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

MDR Year MDR Reports MDR Events
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 1705 1705
Device Dislodged or Dislocated 582 582
Insufficient Information 259 259
Fracture 239 239
Appropriate Term/Code Not Available 187 187
Osseointegration Problem 135 135
Loss of Osseointegration 135 135
Break 134 134
Naturally Worn 109 109
Difficult to Insert 102 102
Detachment of Device or Device Component 78 78
Loosening of Implant Not Related to Bone-Ingrowth 75 75
Loss of or Failure to Bond 69 69
Unstable 52 52
Loose or Intermittent Connection 49 49
Migration 45 45
Patient Device Interaction Problem 38 38
Material Deformation 25 25
Migration or Expulsion of Device 24 24
Malposition of Device 20 20
Device-Device Incompatibility 19 19
Material Erosion 18 18
Noise, Audible 18 18
Use of Device Problem 17 17
Off-Label Use 15 15
Positioning Problem 15 15
Inadequacy of Device Shape and/or Size 14 14
Manufacturing, Packaging or Shipping Problem 12 12
Patient-Device Incompatibility 12 12
Packaging Problem 12 12
Fitting Problem 11 11
Failure to Osseointegrate 9 9
Inaccurate Information 9 9
Tear, Rip or Hole in Device Packaging 8 8
Mechanical Jam 8 8
Difficult to Advance 7 7
Connection Problem 7 7
Mechanical Problem 7 7
Disassembly 7 7
Failure To Adhere Or Bond 7 7
Crack 7 7
Positioning Failure 6 6
Difficult to Remove 6 6
Material Twisted/Bent 6 6
Failure to Advance 6 6
Device Damaged Prior to Use 6 6
Material Split, Cut or Torn 6 6
Therapeutic or Diagnostic Output Failure 6 6
Separation Problem 5 5
Component Missing 5 5
Device Markings/Labelling Problem 5 5
Unintended System Motion 5 5
Device Slipped 4 4
Difficult or Delayed Positioning 4 4
Defective Component 4 4
Microbial Contamination of Device 4 4
Unintended Movement 4 4
Separation Failure 3 3
Contamination /Decontamination Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Detachment Of Device Component 3 3
Corroded 3 3
Material Fragmentation 3 3
Material Separation 3 3
Device Appears to Trigger Rejection 3 3
Nonstandard Device 2 2
Unexpected Therapeutic Results 2 2
Metal Shedding Debris 2 2
Material Disintegration 2 2
Entrapment of Device 2 2
Output Problem 2 2
Dull, Blunt 2 2
No Apparent Adverse Event 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 2 2
Premature Separation 1 1
Protective Measures Problem 1 1
Failure to Disconnect 1 1
Defective Device 1 1
Biocompatibility 1 1
Solder Joint Fracture 1 1
Improper or Incorrect Procedure or Method 1 1
Activation, Positioning or Separation Problem 1 1
Compatibility Problem 1 1
Disconnection 1 1
Decoupling 1 1
Degraded 1 1
Material Rupture 1 1
Delivered as Unsterile Product 1 1
Misassembled 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 982 982
Pain 913 913
Unspecified Infection 849 849
Joint Dislocation 483 483
No Clinical Signs, Symptoms or Conditions 258 258
Inadequate Osseointegration 236 236
Not Applicable 215 215
Joint Laxity 194 194
Loss of Range of Motion 191 191
Bone Fracture(s) 174 174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 174
Failure of Implant 154 154
Insufficient Information 150 150
Unspecified Tissue Injury 128 128
No Information 122 122
No Consequences Or Impact To Patient 119 119
No Known Impact Or Consequence To Patient 84 84
Hematoma 83 83
Limited Mobility Of The Implanted Joint 73 73
Discomfort 63 63
Injury 58 58
Osteolysis 56 56
Fall 52 52
Muscular Rigidity 47 47
Nerve Damage 38 38
Tissue Damage 38 38
Joint Disorder 34 34
Ossification 25 25
Implant Pain 24 24
Muscle/Tendon Damage 23 23
Unspecified Musculoskeletal problem 22 22
Foreign Body Reaction 22 22
Inflammation 21 21
Adhesion(s) 20 20
Stroke/CVA 19 19
Death 19 19
Bacterial Infection 17 17
Erosion 17 17
Numbness 16 16
Foreign Body In Patient 14 14
Patient Problem/Medical Problem 14 14
Hypersensitivity/Allergic reaction 14 14
Pneumonia 14 14
Fatigue 13 13
Scar Tissue 12 12
Swelling 12 12
Subluxation 12 12
No Patient Involvement 11 11
Sepsis 11 11
Pulmonary Embolism 11 11
Osteopenia/ Osteoporosis 9 9
Post Operative Wound Infection 9 9
Reaction 9 9
Impaired Healing 8 8
Metal Related Pathology 8 8
Fluid Discharge 7 7
Arthritis 7 7
Edema 7 7
Cyst(s) 6 6
Pocket Erosion 6 6
Ambulation Difficulties 6 6
Swelling/ Edema 6 6
Device Embedded In Tissue or Plaque 5 5
Fracture, Arm 5 5
Muscle Weakness 5 5
Neurological Deficit/Dysfunction 5 5
Seroma 5 5
Synovitis 4 4
Weakness 4 4
Disability 4 4
Muscle Hypotonia 4 4
Thrombosis/Thrombus 4 4
Limb Fracture 3 3
Paresthesia 3 3
Unspecified Mental, Emotional or Behavioural Problem 3 3
Non-union Bone Fracture 3 3
Arthralgia 3 3
Rupture 3 3
Debris, Bone Shedding 3 3
Abscess 3 3
Wound Dehiscence 2 2
Angina 2 2
Arrhythmia 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Erythema 2 2
Fever 2 2
Burning Sensation 2 2
Tingling 2 2
Thrombosis 2 2
Staphylococcus Aureus 2 2
Pulmonary Edema 2 2
Inadequate Pain Relief 2 2
Ischemic Heart Disease 2 2
Fibrosis 2 2
Cognitive Changes 2 2
Thromboembolism 2 2
Tissue Breakdown 2 2
Heart Failure/Congestive Heart Failure 2 2
Peripheral Nervous Injury 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
-
-