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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device prosthesis, elbow, hemi-, radial, polymer
Product CodeKWI
Regulation Number 888.3170
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 214 214
2020 118 118
2021 44 44
2022 44 76
2023 77 77
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 170 182
Device Slipped 70 70
Detachment of Device or Device Component 47 47
Loose or Intermittent Connection 41 50
Loosening of Implant Not Related to Bone-Ingrowth 40 40
Appropriate Term/Code Not Available 33 33
Unintended Movement 32 32
Device Dislodged or Dislocated 24 42
Insufficient Information 14 14
Inadequacy of Device Shape and/or Size 13 13
Migration 12 14
Material Separation 10 10
Inaccurate Information 7 7
Mechanical Problem 7 7
Fracture 7 7
Naturally Worn 6 6
Patient Device Interaction Problem 6 6
Loss of Osseointegration 4 4
Material Deformation 4 4
Noise, Audible 4 4
Patient-Device Incompatibility 4 4
Component Missing 4 4
Migration or Expulsion of Device 3 3
Unstable 3 3
Break 3 3
Fitting Problem 2 2
Misassembly by Users 2 2
Osseointegration Problem 2 11
Material Integrity Problem 1 1
Degraded 1 1
Use of Device Problem 1 1
Connection Problem 1 1
Positioning Failure 1 1
Physical Resistance/Sticking 1 1
Packaging Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 162 162
No Code Available 110 110
Failure of Implant 87 87
Loss of Range of Motion 63 63
No Known Impact Or Consequence To Patient 40 40
Ossification 34 34
Insufficient Information 33 61
Injury 29 29
Osteolysis 26 26
No Information 26 26
Bone Fracture(s) 26 28
No Clinical Signs, Symptoms or Conditions 14 14
Joint Dislocation 11 20
Weakness 11 11
Muscular Rigidity 10 10
Discomfort 9 9
Unspecified Infection 9 11
Arthritis 8 8
Implant Pain 8 8
Metal Related Pathology 7 7
Tissue Damage 7 7
Scar Tissue 6 6
Nerve Damage 5 5
Bacterial Infection 5 5
Inflammation 5 5
Fatigue 5 5
Joint Laxity 5 14
Unspecified Tissue Injury 5 5
Swelling/ Edema 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hypoesthesia 4 4
Osteopenia/ Osteoporosis 4 4
Limited Mobility Of The Implanted Joint 4 4
Swelling 4 4
Cyst(s) 3 3
Inadequate Osseointegration 3 12
Unspecified Musculoskeletal problem 3 3
Bone Shedding Debris 2 2
Muscle/Tendon Damage 2 2
Impaired Healing 2 2
Joint Disorder 2 2
Erythema 2 2
Erosion 2 2
Calcium Deposits/Calcification 2 2
Failure to Anastomose 2 2
Anemia 2 2
Synovitis 2 2
Hypersensitivity/Allergic reaction 2 2
Therapeutic Response, Decreased 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 1 1
Sepsis 1 1
No Consequences Or Impact To Patient 1 1
Myalgia 1 1
Adhesion(s) 1 1
Foreign Body Reaction 1 1
Hemorrhage/Bleeding 1 1
Fracture, Arm 1 1
Reaction 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Ischemia Stroke 1 1
Unspecified Heart Problem 1 1
Renal Impairment 1 1
Subluxation 1 1
Ankylosis 1 1
Joint Contracture 1 1
Device Embedded In Tissue or Plaque 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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