• 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, 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)
2017 2018 2019 2020 2021 2022
3 3 4 1 1 0

MDR Year MDR Reports MDR Events
2017 7 7
2018 13 13
2019 44 44
2020 36 36
2021 28 28
2022 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 89 89
Insufficient Information 32 32
Migration 21 21
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
Malposition of Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Patient-Device Incompatibility 4 4
Break 4 4
Fracture 3 3
Device Dislodged or Dislocated 3 3
Failure to Osseointegrate 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Unclear Information 1 1
Material Deformation 1 1
Naturally Worn 1 1
Material Erosion 1 1
Device Appears to Trigger Rejection 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 128 128
Loss of Range of Motion 22 22
Failure of Implant 21 21
Insufficient Information 13 13
No Clinical Signs, Symptoms or Conditions 12 12
Unspecified Infection 11 11
Inflammation 11 11
Swelling 9 9
Ambulation Difficulties 8 8
Swelling/ Edema 8 8
Joint Swelling 7 7
Implant Pain 5 5
No Code Available 5 5
No Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Patient Problem/Medical Problem 4 4
Discomfort 3 3
Erosion 3 3
Bone Fracture(s) 3 3
Cyst(s) 2 2
Synovitis 2 2
Nerve Damage 2 2
Foreign Body Reaction 2 2
Osteolysis 2 2
Inadequate Pain Relief 2 2
No Known Impact Or Consequence To Patient 2 2
Post Operative Wound Infection 2 2
Limited Mobility Of The Implanted Joint 2 2
Joint Laxity 2 2
Sleep Dysfunction 1 1
Joint Dislocation 1 1
Device Embedded In Tissue or Plaque 1 1
Weight Changes 1 1
Inadequate Osseointegration 1 1
Reaction 1 1
Fungal Infection 1 1
Local Reaction 1 1
No Consequences Or Impact To Patient 1 1
Therapeutic Response, Decreased 1 1
Purulent Discharge 1 1
Edema 1 1
Fall 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Arthritis 1 1
Bacterial Infection 1 1

-
-