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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)
2019 2020 2021 2022 2023 2024
4 1 1 0 0 0

MDR Year MDR Reports MDR Events
2019 44 44
2020 36 36
2021 28 28
2022 94 94
2023 19 19
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 96 96
Insufficient Information 31 31
Migration 27 27
Unintended Movement 13 13
Patient Device Interaction Problem 9 9
Degraded 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 5 5
Material Fragmentation 5 5
Break 4 4
Patient-Device Incompatibility 4 4
Naturally Worn 3 3
Device Dislodged or Dislocated 2 2
Fracture 2 2
Delivered as Unsterile Product 2 2
Failure to Osseointegrate 2 2
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Unclear Information 1 1
Device Appears to Trigger Rejection 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Material Erosion 1 1
Material Deformation 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 117 117
Loss of Range of Motion 32 32
Failure of Implant 24 24
Insufficient Information 22 22
Implant Pain 20 20
Ambulation Difficulties 13 13
No Clinical Signs, Symptoms or Conditions 12 12
Unspecified Infection 11 11
Inflammation 10 10
Swelling/ Edema 10 10
Discomfort 9 9
Swelling 6 6
Nerve Damage 6 6
Cyst(s) 4 4
Osteolysis 4 4
No Information 4 4
No Code Available 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Patient Problem/Medical Problem 3 3
Irritability 3 3
Joint Swelling 3 3
Arthritis 3 3
Bone Fracture(s) 3 3
Hypersensitivity/Allergic reaction 2 2
Erosion 2 2
Foreign Body Reaction 2 2
Post Operative Wound Infection 2 2
No Known Impact Or Consequence To Patient 2 2
Joint Laxity 2 2
Skin Inflammation/ Irritation 1 1
Device Embedded In Tissue or Plaque 1 1
Weight Changes 1 1
Inadequate Osseointegration 1 1
Sleep Dysfunction 1 1
Reaction 1 1
Synovitis 1 1
Therapeutic Response, Decreased 1 1
Bacterial Infection 1 1
Purulent Discharge 1 1
Edema 1 1
Fall 1 1
Local Reaction 1 1

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