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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, metatarsophalangeal joint cartilage replacement implant
Definition The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint.
Product CodePNW
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 4 3 3 4 1 1 0 0 0

MDR Year MDR Reports MDR Events
2016 1 1
2017 7 7
2018 13 13
2019 44 44
2020 36 36
2021 28 28
2022 94 94
2023 19 19
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 109 109
Insufficient Information 33 33
Migration 28 28
Unintended Movement 13 13
Patient Device Interaction Problem 9 9
Degraded 8 8
Material Fragmentation 8 8
Therapeutic or Diagnostic Output Failure 7 7
Material Integrity Problem 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Malposition of Device 6 6
Break 4 4
Patient-Device Incompatibility 4 4
Device Dislodged or Dislocated 3 3
Fracture 3 3
Naturally Worn 3 3
Failure to Osseointegrate 2 2
Delivered as Unsterile Product 2 2
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 1 1
Biocompatibility 1 1
Noise, Audible 1 1
Material Deformation 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Appears to Trigger Rejection 1 1
Unexpected Therapeutic Results 1 1
Unclear Information 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 129 129
Loss of Range of Motion 35 35
Failure of Implant 25 25
Insufficient Information 22 22
Implant Pain 21 21
Ambulation Difficulties 15 15
No Clinical Signs, Symptoms or Conditions 12 12
Unspecified Infection 11 11
Inflammation 11 11
Swelling/ Edema 10 10
Discomfort 10 10
Swelling 9 9
Nerve Damage 8 8
Joint Swelling 7 7
No Code Available 5 5
Irritability 4 4
Patient Problem/Medical Problem 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Information 4 4
Osteolysis 4 4
Cyst(s) 4 4
Arthritis 3 3
Inadequate Pain Relief 3 3
Erosion 3 3
Bone Fracture(s) 3 3
Foreign Body Reaction 2 2
Post Operative Wound Infection 2 2
No Known Impact Or Consequence To Patient 2 2
Synovitis 2 2
Limited Mobility Of The Implanted Joint 2 2
Joint Laxity 2 2
Hypersensitivity/Allergic reaction 2 2
Ossification 1 1
Local Reaction 1 1
Edema 1 1
Purulent Discharge 1 1
Skin Inflammation/ Irritation 1 1
Fall 1 1
Inadequate Osseointegration 1 1
Reaction 1 1
Fungal Infection 1 1
Therapeutic Response, Decreased 1 1
Bacterial Infection 1 1
Joint Dislocation 1 1
No Consequences Or Impact To Patient 1 1
Weight Changes 1 1
Sleep Dysfunction 1 1
High Blood Pressure/ Hypertension 1 1
Device Embedded In Tissue or Plaque 1 1

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