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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
Product CodeKWI
Regulation Number 888.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOPOLY, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
IGNITE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SKELETAL DYNAMICS INC
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 29 29
2015 103 103
2016 138 138
2017 360 360
2018 202 202
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 272 284
Unintended Movement 200 200
Insufficient Information 101 101
Loose or Intermittent Connection 98 107
Device Slipped 96 96
Device Dislodged or Dislocated 82 100
Detachment Of Device Component 67 67
Detachment of Device or Device Component 65 65
Migration or Expulsion of Device 55 55
Appropriate Term/Code Not Available 52 52
Loosening of Implant Not Related to Bone-Ingrowth 47 47
Material Separation 47 47
Unstable 39 39
Break 27 27
Device Operates Differently Than Expected 24 24
Migration 23 25
Inadequacy of Device Shape and/or Size 18 18
Fracture 15 15
Patient-Device Incompatibility 14 14
Mechanical Problem 13 13
Naturally Worn 12 12
Nonstandard Device 10 10
Failure To Adhere Or Bond 10 10
Component Missing 9 9
Noise, Audible 9 9
Fitting Problem 9 9
Disassembly 8 8
Inaccurate Information 7 7
Patient Device Interaction Problem 6 6
Loss of Osseointegration 6 6
Malposition of Device 6 6
Difficult to Advance 5 5
Improper or Incorrect Procedure or Method 5 5
Material Integrity Problem 4 4
Failure to Osseointegrate 4 4
Packaging Problem 4 4
Material Deformation 4 4
Component or Accessory Incompatibility 4 4
Device Packaging Compromised 3 3
Failure to Align 3 3
Positioning Problem 3 3
Metal Shedding Debris 3 3
Connection Problem 3 3
Use of Device Problem 2 2
Loss of or Failure to Bond 2 2
Osseointegration Problem 2 11
Difficult to Insert 2 2
Material Erosion 2 2
Misassembly by Users 2 2
Device Issue 2 2
Unsealed Device Packaging 2 2
Physical Resistance/Sticking 2 2
Sticking 1 1
Unintended Collision 1 1
Material Fragmentation 1 1
Material Too Rigid or Stiff 1 1
Positioning Failure 1 1
Off-Label Use 1 1
Human Factors Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Rupture 1 1
Moisture Damage 1 1
Defective Device 1 1
Missing Value Reason 1 1
Device Expiration Issue 1 1
Crack 1 1
Tear, Rip or Hole in Device Packaging 1 1
Misconnection 1 1
Difficult to Remove 1 1
Expiration Date Error 1 1
Material Disintegration 1 1
Device Operational Issue 1 1
Delamination 1 1
Degraded 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 379 379
No Code Available 345 345
Failure of Implant 271 271
No Known Impact Or Consequence To Patient 165 165
Loss of Range of Motion 104 104
No Information 95 95
Osteolysis 53 53
Ossification 39 39
Bone Fracture(s) 38 40
Injury 36 36
Insufficient Information 33 61
Unspecified Infection 27 29
Limited Mobility Of The Implanted Joint 20 20
Joint Dislocation 19 28
Discomfort 18 18
Arthritis 15 15
Weakness 14 14
No Clinical Signs, Symptoms or Conditions 14 14
Tissue Damage 13 13
Fall 13 13
Swelling 13 13
Nerve Damage 12 12
Muscular Rigidity 11 11
Inflammation 11 11
Non-union Bone Fracture 11 11
Patient Problem/Medical Problem 11 11
Impaired Healing 10 10
No Consequences Or Impact To Patient 8 8
Implant Pain 8 8
Metal Related Pathology 7 7
Sedation 6 6
Scar Tissue 6 6
Bacterial Infection 6 6
Erosion 6 6
Fatigue 5 5
Cyst(s) 5 5
Reaction 5 5
Hypoesthesia 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
Fracture, Arm 4 4
Ambulation Difficulties 4 4
Inadequate Osseointegration 4 13
Osteopenia/ Osteoporosis 4 4
Irritation 4 4
Hypersensitivity/Allergic reaction 4 4
Death 3 3
Foreign Body In Patient 3 3
Toxicity 3 3
Joint Disorder 3 3
Unspecified Musculoskeletal problem 3 3
Bone Shedding Debris 2 2
Muscle/Tendon Damage 2 2
Arthralgia 2 2
Therapeutic Response, Decreased 2 2
Seroma 2 2
Device Embedded In Tissue or Plaque 2 2
Numbness 2 2
Anemia 2 2
Erythema 2 2
Calcium Deposits/Calcification 2 2
Failure to Anastomose 2 2
Wound Dehiscence 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 2 2
Muscle Weakness 2 2
Synovitis 2 2
Sepsis 1 1
Rash 1 1
Staphylococcus Aureus 1 1
Adhesion(s) 1 1
Capsular Contracture 1 1
Ecchymosis 1 1
Foreign Body Reaction 1 1
Hemorrhage/Bleeding 1 1
Neck Stiffness 1 1
No Patient Involvement 1 1
Not Applicable 1 1
Test Result 1 1
Complaint, Ill-Defined 1 1
Rupture 1 1
Myalgia 1 1
Ankylosis 1 1
Joint Contracture 1 1
Ischemia Stroke 1 1
Unspecified Heart Problem 1 1
Renal Impairment 1 1
Subluxation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II May-31-2017
2 Biomet, Inc. II May-13-2014
3 Howmedica Osteonics Corp. II Aug-08-2018
4 Skeletal Dynamics II Dec-12-2014
5 Small Bone Innovations, Inc. II Oct-29-2013
6 Synthes (USA) Products LLC II May-12-2022
7 Synthes (USA) Products LLC II Feb-02-2017
8 Synthes USA HQ, Inc. II May-03-2013
9 Wright Medical Technology Inc II Sep-21-2020
10 Wright Medical Technology, Inc. II Oct-04-2022
11 Wright Medical Technology, Inc. II Feb-06-2020
12 Zimmer Biomet, Inc. II Dec-20-2017
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