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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
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 8 8
2022 65 65
2023 26 26
2024 18 18
2025 8 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 50 52
Migration 29 29
Loss of Osseointegration 15 15
Loosening of Implant Not Related to Bone-Ingrowth 10 10
Naturally Worn 6 6
Osseointegration Problem 6 6
Fracture 5 5
Device Dislodged or Dislocated 5 5
Break 2 2
Degraded 2 2
Failure to Osseointegrate 2 2
Biocompatibility 2 2
Device Contaminated During Manufacture or Shipping 1 1
Patient-Device Incompatibility 1 1
Unintended Movement 1 1
Expiration Date Error 1 1
Material Integrity Problem 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
Inadequacy of Device Shape and/or Size 1 1
Nonstandard Device 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 48 48
Implant Pain 13 13
Insufficient Information 9 9
Inadequate Osseointegration 8 8
Loss of Range of Motion 8 8
Unspecified Infection 7 9
Bone Fracture(s) 7 7
Pain 7 7
Osteolysis 5 5
Arthralgia 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Inflammation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Osteopenia/ Osteoporosis 3 3
Post Operative Wound Infection 3 3
Joint Dislocation 2 2
Synovitis 2 2
Swelling/ Edema 2 2
Bacterial Infection 2 2
Rheumatoid Arthritis 1 1
Pneumothorax 1 1
Solid Tumour 1 1
Metal Related Pathology 1 1
Necrosis 1 1
Hematoma 1 1
No Known Impact Or Consequence To Patient 1 1
Fever 1 1
Discomfort 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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