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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
Regulation Description Wrist joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJWJ
Regulation Number 888.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 37 37
2018 31 31
2019 127 127
2020 34 34
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 101 101
Insufficient Information 51 51
Material Disintegration 20 20
Migration or Expulsion of Device 15 15
Loose or Intermittent Connection 13 13
Break 7 7
Therapeutic or Diagnostic Output Failure 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Inadequacy of Device Shape and/or Size 6 6
Device Dislodged or Dislocated 4 4
Loss of or Failure to Bond 4 4
Appropriate Term/Code Not Available 4 4
Failure To Adhere Or Bond 2 2
Material Erosion 2 2
Fracture 2 2
Labelling, Instructions for Use or Training Problem 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1
Material Separation 1 1
Device Slipped 1 1
Metal Shedding Debris 1 1
Loss of Osseointegration 1 1
Expiration Date Error 1 1
Patient-Device Incompatibility 1 1
Device Handling Problem 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 45 45
Osteolysis 41 41
Pain 38 38
No Known Impact Or Consequence To Patient 35 35
Unspecified Infection 24 24
Loss of Range of Motion 20 20
No Information 13 13
Synovitis 10 10
Patient Problem/Medical Problem 8 8
Injury 7 7
Tissue Damage 7 7
Burning Sensation 7 7
Scar Tissue 7 7
Tingling 6 6
Failure of Implant 6 6
Swelling 5 5
Bone Fracture(s) 4 4
Nerve Damage 4 4
Joint Dislocation 4 4
Post Operative Wound Infection 4 4
Inadequate Osseointegration 3 3
Inflammation 3 3
Wound Dehiscence 3 3
Weakness 3 3
Cyst(s) 2 2
Limited Mobility Of The Implanted Joint 2 2
Numbness 1 1
Arthralgia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Erythema 1 1
Fall 1 1
Ossification 1 1
Adhesion(s) 1 1
Muscular Rigidity 1 1

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