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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 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 212 224
Device Slipped 70 70
Detachment of Device or Device Component 50 50
Loosening of Implant Not Related to Bone-Ingrowth 46 46
Loose or Intermittent Connection 41 50
Appropriate Term/Code Not Available 33 33
Unintended Movement 32 32
Device Dislodged or Dislocated 30 48
Insufficient Information 24 32
Osseointegration Problem 21 39
Inadequacy of Device Shape and/or Size 13 13
Migration 12 14
Material Separation 10 10
Unstable 9 11
Mechanical Problem 7 7
Fracture 7 7
Inaccurate Information 7 7
Patient Device Interaction Problem 6 6
Naturally Worn 6 6
Patient-Device Incompatibility 4 4
Component Missing 4 4
Material Deformation 4 4
Loss of Osseointegration 4 4
Noise, Audible 4 4
Break 3 3
Migration or Expulsion of Device 3 3
Fitting Problem 2 2
Separation Failure 2 2
Packaging Problem 2 2
Misassembly by Users 2 2
Physical Resistance/Sticking 1 1
Expiration Date Error 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Moisture Damage 1 1
Degraded 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 171 171
No Code Available 110 110
Failure of Implant 92 92
Loss of Range of Motion 65 65
Insufficient Information 43 71
Ossification 42 42
Osteolysis 41 41
No Known Impact Or Consequence To Patient 40 40
Injury 29 29
Bone Fracture(s) 28 30
No Information 26 26
Inadequate Osseointegration 23 41
No Clinical Signs, Symptoms or Conditions 17 17
Arthritis 14 14
Joint Laxity 13 24
Joint Dislocation 12 21
Weakness 11 11
Unspecified Infection 11 13
Muscular Rigidity 10 10
Discomfort 9 9
Implant Pain 8 8
Tissue Damage 7 7
Metal Related Pathology 7 7
Swelling/ Edema 7 7
Scar Tissue 6 6
Fatigue 5 5
Inflammation 5 5
Unspecified Tissue Injury 5 5
Subluxation 5 5
Bacterial Infection 5 5
Erosion 5 5
Nerve Damage 5 5
Limited Mobility Of The Implanted Joint 4 4
Osteopenia/ Osteoporosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hypoesthesia 4 4
Swelling 4 4
Nausea 3 3
Unspecified Musculoskeletal problem 3 3
Cyst(s) 3 3
Muscle/Tendon Damage 3 3
Therapeutic Response, Decreased 2 2
Calcium Deposits/Calcification 2 2
Joint Contracture 2 2
Failure to Anastomose 2 2
Erythema 2 2
Bone Shedding Debris 2 2
Neurological Deficit/Dysfunction 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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