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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device osseoanchored prostheses for the rehabilitation of transfemoral amputees
Definition The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.
Product CodePJY
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 0 0 0 0 1 2 0 2 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 16 16
2019 9 9
2020 14 14
2021 25 25
2022 26 26
2023 60 60
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 57 57
Adverse Event Without Identified Device or Use Problem 42 42
Mechanical Problem 22 22
Insufficient Information 20 20
Fracture 9 9
Device Dislodged or Dislocated 8 8
Microbial Contamination of Device 8 8
Device Fell 6 6
Osseointegration Problem 4 4
Loss of Osseointegration 3 3
Failure to Osseointegrate 3 3
Loose or Intermittent Connection 2 2
Break 2 2
Off-Label Use 2 2
Device Slipped 2 2
Unintended Movement 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1
Unclear Information 1 1
Loss of or Failure to Bond 1 1
Migration or Expulsion of Device 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Improper or Incorrect Procedure or Method 1 1
Activation, Positioning or Separation Problem 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Fall 29 29
Implant Pain 15 15
Insufficient Information 15 15
Fluid Discharge 13 13
Failure of Implant 13 13
Unspecified Infection 13 13
No Code Available 12 12
Osteomyelitis 9 9
Pain 8 8
No Known Impact Or Consequence To Patient 7 7
Bacterial Infection 4 4
Bruise/Contusion 3 3
Inadequate Osseointegration 3 3
No Consequences Or Impact To Patient 3 3
Missing Value Reason 2 2
Thrombosis/Thrombus 1 1
Limb Fracture 1 1
Localized Skin Lesion 1 1
External Prosthetic Device Pain 1 1
Subclinical Infection 1 1
Injury 1 1
Hip Fracture 1 1
Osteolysis 1 1
Abscess 1 1
Death 1 1
Bone Fracture(s) 1 1
Headache 1 1

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