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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained
Product CodeJWJ
Regulation Number 888.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFE SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 11 11
2015 7 7
2016 48 48
2017 37 37
2018 31 31
2019 127 127
2020 34 34
2021 8 8
2022 65 65
2023 26 26
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 161 161
Insufficient Information 62 62
Migration 28 28
Material Disintegration 21 21
Migration or Expulsion of Device 18 18
Loss of Osseointegration 16 16
Loose or Intermittent Connection 14 14
Break 12 12
Naturally Worn 12 12
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Fracture 8 8
Device Dislodged or Dislocated 7 7
Therapeutic or Diagnostic Output Failure 7 7
Osseointegration Problem 6 6
Appropriate Term/Code Not Available 6 6
Inadequacy of Device Shape and/or Size 6 6
Patient-Device Incompatibility 5 5
Unstable 4 4
Material Erosion 4 4
Loss of or Failure to Bond 4 4
Protective Measures Problem 4 4
Failure To Adhere Or Bond 3 3
Device Slipped 3 3
Compatibility Problem 3 3
Material Integrity Problem 3 3
Device Operates Differently Than Expected 3 3
Failure to Osseointegrate 2 2
Biocompatibility 2 2
Delamination 2 2
Degraded 2 2
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1
Crack 1 1
Device Expiration Issue 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Contamination With Biological Material 1 1
Metal Shedding Debris 1 1
Expiration Date Error 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Unintended Movement 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 58 58
Failure of Implant 54 54
No Code Available 53 53
Osteolysis 49 49
No Known Impact Or Consequence To Patient 38 38
Unspecified Infection 36 36
Loss of Range of Motion 27 27
No Information 24 24
Synovitis 13 13
Inflammation 12 12
Inadequate Osseointegration 11 11
Patient Problem/Medical Problem 11 11
Swelling 10 10
Implant Pain 9 9
Insufficient Information 8 8
Tissue Damage 8 8
Scar Tissue 8 8
Bone Fracture(s) 8 8
Burning Sensation 7 7
Injury 7 7
Post Operative Wound Infection 7 7
Tingling 6 6
Nerve Damage 6 6
Arthralgia 5 5
Joint Dislocation 4 4
No Patient Involvement 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Discomfort 3 3
Osteopenia/ Osteoporosis 3 3
Limited Mobility Of The Implanted Joint 3 3
Weakness 3 3
Foreign Body Reaction 3 3
Hypersensitivity/Allergic reaction 3 3
Wound Dehiscence 3 3
Capsular Contracture 3 3
Cyst(s) 2 2
Ossification 2 2
Bacterial Infection 2 2
Erosion 2 2
Skin Irritation 2 2
Rash 2 2
Reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Swelling/ Edema 2 2
Test Result 1 1
Numbness 1 1
Collapse 1 1
Joint Laxity 1 1
Malunion of Bone 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Muscular Rigidity 1 1
Necrosis 1 1
Pneumothorax 1 1
No Consequences Or Impact To Patient 1 1
Rupture 1 1
Hematoma 1 1
Infiltration into Tissue 1 1
Adhesion(s) 1 1
Arthritis 1 1
Erythema 1 1
Fall 1 1
Fever 1 1
Fistula 1 1

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