Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 224 236
Loosening of Implant Not Related to Bone-Ingrowth 53 53
Detachment of Device or Device Component 52 52
Device Slipped 35 35
Device Dislodged or Dislocated 32 51
Osseointegration Problem 23 41
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 10 10
Fracture 9 9
Material Separation 8 8
Inaccurate Information 7 7
Naturally Worn 7 7
Patient Device Interaction Problem 6 6
Unintended Movement 5 5
Break 5 5
Loss of Osseointegration 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
Packaging Problem 2 2
Misassembly by Users 2 2
Separation Failure 2 2
Malposition of Device 2 2
Degraded 1 1
Use of Device Problem 1 1
Moisture Damage 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Expiration Date Error 1 1
Connection Problem 1 1
Physical Resistance/Sticking 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 113 113
Loss of Range of Motion 76 76
Failure of Implant 73 74
Insufficient Information 68 96
Ossification 38 38
No Code Available 33 33
Inadequate Osseointegration 26 44
Metal Related Pathology 26 26
Bone Fracture(s) 26 28
Osteolysis 24 24
Joint Laxity 20 31
Unspecified Infection 19 21
No Clinical Signs, Symptoms or Conditions 18 18
Subluxation 13 13
No Information 13 13
Implant Pain 12 12
Arthritis 11 11
Muscular Rigidity 10 10
Joint Dislocation 10 19
No Known Impact Or Consequence To Patient 9 9
Discomfort 9 9
Scar Tissue 8 8
Tissue Damage 7 7
Swelling/ Edema 7 7
Unspecified Tissue Injury 6 6
Fatigue 5 5
Weakness 5 5
Bacterial Infection 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Erosion 5 5
Inflammation 4 4
Osteopenia/ Osteoporosis 4 4
Joint Contracture 4 4
Limited Mobility Of The Implanted Joint 4 4
Nerve Damage 4 4
Unspecified Musculoskeletal problem 3 3
Nausea 3 3
Muscle/Tendon Damage 3 3
Therapeutic Response, Decreased 2 2
Limb Fracture 2 2
Failure to Anastomose 2 2
Peripheral Nervous Injury 2 2
Hypoesthesia 2 2
Swelling 2 2
Bone Shedding Debris 2 2
Injury 2 2
Neurological Deficit/Dysfunction 2 2
Anemia 2 2
Synovitis 2 2
Hypersensitivity/Allergic reaction 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
-
-