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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 77
2024 124 124
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 159 171
Detachment of Device or Device Component 45 45
Device Slipped 35 35
Device Dislodged or Dislocated 32 50
Loosening of Implant Not Related to Bone-Ingrowth 31 31
Osseointegration Problem 21 39
Insufficient Information 19 27
Loose or Intermittent Connection 16 25
Appropriate Term/Code Not Available 13 13
Unstable 12 14
Migration 11 13
Inadequacy of Device Shape and/or Size 10 10
Material Separation 8 8
Inaccurate Information 7 7
Fracture 6 6
Patient Device Interaction Problem 6 6
Naturally Worn 5 5
Unintended Movement 5 5
Loss of Osseointegration 5 5
Noise, Audible 4 4
Patient-Device Incompatibility 4 4
Material Deformation 4 4
Break 3 3
Migration or Expulsion of Device 3 3
Component Missing 3 3
Separation Failure 2 2
Malposition of Device 2 2
Misassembly by Users 2 2
Packaging Problem 2 2
Positioning Failure 2 2
Moisture Damage 1 1
Fitting Problem 1 1
Use of Device Problem 1 1
Expiration Date Error 1 1
Connection Problem 1 1
Physical Resistance/Sticking 1 1
Degraded 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 102 102
Failure of Implant 63 63
Insufficient Information 45 73
Loss of Range of Motion 44 44
No Code Available 33 33
Bone Fracture(s) 25 27
Osteolysis 24 24
Inadequate Osseointegration 24 42
Unspecified Infection 19 21
Joint Laxity 18 29
Ossification 17 17
No Clinical Signs, Symptoms or Conditions 17 17
No Information 13 13
Subluxation 13 13
Implant Pain 12 12
Arthritis 11 11
Joint Dislocation 10 19
Muscular Rigidity 10 10
No Known Impact Or Consequence To Patient 9 9
Discomfort 8 8
Tissue Damage 7 7
Metal Related Pathology 7 7
Swelling/ Edema 7 7
Scar Tissue 6 6
Unspecified Tissue Injury 6 6
Weakness 5 5
Bacterial Infection 5 5
Erosion 5 5
Fatigue 5 5
Nerve Damage 4 4
Limited Mobility Of The Implanted Joint 4 4
Osteopenia/ Osteoporosis 4 4
Inflammation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Nausea 3 3
Unspecified Musculoskeletal problem 3 3
Muscle/Tendon Damage 3 3
Bone Shedding Debris 2 2
Joint Contracture 2 2
Hypersensitivity/Allergic reaction 2 2
Anemia 2 2
Failure to Anastomose 2 2
Neurological Deficit/Dysfunction 2 2
Hypoesthesia 2 2
Injury 2 2
Swelling 2 2
Synovitis 2 2
Therapeutic Response, Decreased 2 2
Ankylosis 1 1
Infiltration into Tissue 1 1

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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