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 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 189 201
Detachment of Device or Device Component 39 39
Loosening of Implant Not Related to Bone-Ingrowth 38 38
Device Dislodged or Dislocated 26 45
Osseointegration Problem 23 41
Device Slipped 18 18
Corroded 17 17
Migration 14 16
Insufficient Information 12 20
Unstable 11 13
Fracture 8 8
Inaccurate Information 7 7
Patient Device Interaction Problem 6 6
Inadequacy of Device Shape and/or Size 6 6
Loose or Intermittent Connection 6 15
Break 5 5
Migration or Expulsion of Device 3 3
Patient-Device Incompatibility 3 3
Component Missing 3 3
Appropriate Term/Code Not Available 3 3
Naturally Worn 3 3
Noise, Audible 3 3
Malposition of Device 2 2
Separation Failure 2 2
Material Deformation 2 2
Packaging Problem 2 2
Misassembly by Users 2 2
Loss of Osseointegration 2 2
Fitting Problem 1 1
Physical Resistance/Sticking 1 1
Expiration Date Error 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Moisture Damage 1 1
Degraded 1 1
Positioning Failure 1 1
Material Separation 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 70 70
Insufficient Information 63 91
Loss of Range of Motion 61 61
Failure of Implant 58 59
Ossification 34 34
Inadequate Osseointegration 26 44
Metal Related Pathology 26 26
Joint Laxity 20 31
No Clinical Signs, Symptoms or Conditions 18 18
Bone Fracture(s) 18 20
Osteolysis 17 17
Unspecified Infection 16 18
Subluxation 13 13
Implant Pain 12 12
Discomfort 8 8
Arthritis 7 7
Joint Dislocation 7 16
Swelling/ Edema 7 7
Unspecified Tissue Injury 6 6
Muscular Rigidity 6 6
Erosion 5 5
Joint Contracture 4 4
Scar Tissue 4 4
Bacterial Infection 3 3
Weakness 3 3
Osteopenia/ Osteoporosis 3 3
Unspecified Musculoskeletal problem 3 3
Nausea 3 3
Fatigue 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Bone Shedding Debris 2 2
Anemia 2 2
Peripheral Nervous Injury 2 2
Limb Fracture 2 2
Foreign Body In Patient 1 1
Myalgia 1 1
Renal Impairment 1 1
Fall 1 1
Perforation 1 1
Ankylosis 1 1
Muscle/Tendon Damage 1 1
Inflammation 1 1
Unspecified Heart Problem 1 1
Sepsis 1 1
Hemorrhage/Bleeding 1 1
Neuropathy 1 1
Infiltration into Tissue 1 1
Ischemia Stroke 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 Oct-04-2022
-
-