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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
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 127 127
2020 34 34
2021 8 8
2022 65 65
2023 26 26
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 140 140
Migration 30 30
Material Disintegration 20 20
Insufficient Information 16 16
Loss of Osseointegration 16 16
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Loose or Intermittent Connection 9 9
Therapeutic or Diagnostic Output Failure 7 7
Fracture 6 6
Device Dislodged or Dislocated 6 6
Naturally Worn 6 6
Osseointegration Problem 6 6
Loss of or Failure to Bond 4 4
Break 2 2
Patient-Device Incompatibility 2 2
Material Integrity Problem 2 2
Failure to Osseointegrate 2 2
Appropriate Term/Code Not Available 2 2
Biocompatibility 2 2
Device Slipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unintended Movement 1 1
Expiration Date Error 1 1
Degraded 1 1
Material Fragmentation 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 48 48
Osteolysis 43 43
No Code Available 42 42
No Known Impact Or Consequence To Patient 35 35
Pain 27 27
Loss of Range of Motion 18 18
Inadequate Osseointegration 11 11
Implant Pain 10 10
Bone Fracture(s) 10 10
Synovitis 9 9
Patient Problem/Medical Problem 8 8
Insufficient Information 8 8
Unspecified Infection 7 7
Tissue Damage 7 7
Scar Tissue 7 7
Injury 6 6
Post Operative Wound Infection 6 6
Arthralgia 5 5
Inflammation 4 4
No Information 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Osteopenia/ Osteoporosis 3 3
Nerve Damage 3 3
Joint Dislocation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Limited Mobility Of The Implanted Joint 2 2
Swelling/ Edema 2 2
Bacterial Infection 2 2
Hematoma 1 1
Cyst(s) 1 1
Necrosis 1 1
Fever 1 1
Burning Sensation 1 1
Metal Related Pathology 1 1
Discomfort 1 1
Solid Tumour 1 1
Numbness 1 1
Pneumothorax 1 1
Malunion of Bone 1 1
Joint Laxity 1 1
Infiltration into Tissue 1 1
Arthritis 1 1
Fistula 1 1

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