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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, elbow, hemi-, radial, polymer
Regulation Description Elbow joint radial (hemi-elbow) polymer prosthesis.
Product CodeKWI
Regulation Number 888.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOPOLY, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 118 118
2021 44 44
2022 44 76
2023 77 78
2024 124 124
2025 121 121
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 227 239
Detachment of Device or Device Component 53 53
Loosening of Implant Not Related to Bone-Ingrowth 53 53
Device Slipped 35 35
Device Dislodged or Dislocated 32 51
Osseointegration Problem 24 42
Insufficient Information 19 27
Corroded 17 17
Loose or Intermittent Connection 16 25
Migration 15 17
Appropriate Term/Code Not Available 13 13
Unstable 12 14
Inadequacy of Device Shape and/or Size 11 11
Fracture 11 11
Material Separation 8 8
Naturally Worn 7 7
Inaccurate Information 7 7
Patient Device Interaction Problem 6 6
Break 6 6
Loss of Osseointegration 5 5
Unintended Movement 5 5
Material Deformation 4 4
Patient-Device Incompatibility 4 4
Noise, Audible 4 4
Component Missing 3 3
Migration or Expulsion of Device 3 3
Positioning Failure 2 2
Improper or Incorrect Procedure or Method 2 2
Separation Failure 2 2
Malposition of Device 2 2
Misassembly by Users 2 2
Packaging Problem 2 2
Positioning Problem 1 1
Material Integrity Problem 1 1
Connection Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device-Device Incompatibility 1 1
Fitting Problem 1 1
Use of Device Problem 1 1
Expiration Date Error 1 1
Crack 1 1
Degraded 1 1
Moisture Damage 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 115 115
Loss of Range of Motion 76 76
Failure of Implant 75 76
Insufficient Information 70 98
Ossification 40 40
No Code Available 33 33
Metal Related Pathology 27 27
Bone Fracture(s) 26 28
Inadequate Osseointegration 26 44
Osteolysis 24 24
Unspecified Infection 21 23
Joint Laxity 20 31
No Clinical Signs, Symptoms or Conditions 19 19
No Information 13 13
Subluxation 13 13
Implant Pain 13 13
Arthritis 11 11
Joint Dislocation 10 19
Muscular Rigidity 10 10
No Known Impact Or Consequence To Patient 9 9
Scar Tissue 9 9
Discomfort 9 9
Swelling/ Edema 7 7
Tissue Damage 7 7
Unspecified Tissue Injury 6 6
Fatigue 5 5
Erosion 5 5
Bacterial Infection 5 5
Joint Contracture 5 5
Weakness 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Limited Mobility Of The Implanted Joint 4 4
Inflammation 4 4
Osteopenia/ Osteoporosis 4 4
Nerve Damage 4 4
Muscle/Tendon Damage 3 3
Nausea 3 3
Unspecified Musculoskeletal problem 3 3
Limb Fracture 3 3
Failure to Anastomose 2 2
Peripheral Nervous Injury 2 2
Therapeutic Response, Decreased 2 2
Swelling 2 2
Hypersensitivity/Allergic reaction 2 2
Bone Shedding Debris 2 2
Injury 2 2
Neurological Deficit/Dysfunction 2 2
Hypoesthesia 2 2
Anemia 2 2
Synovitis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II May-12-2022
2 Wright Medical Technology Inc II Sep-21-2020
3 Wright Medical Technology, Inc. II Oct-04-2022
4 Wright Medical Technology, Inc. II Feb-06-2020
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