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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 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 68 68
Adverse Event Without Identified Device or Use Problem 53 53
Mechanical Problem 22 22
Insufficient Information 21 21
Fracture 11 11
Microbial Contamination of Device 8 8
Device Dislodged or Dislocated 8 8
Off-Label Use 6 6
Device Fell 6 6
Osseointegration Problem 6 6
Loss of Osseointegration 5 5
Failure to Osseointegrate 3 3
Break 2 2
Unintended Movement 2 2
Device Slipped 2 2
Appropriate Term/Code Not Available 2 2
Loose or Intermittent Connection 2 2
Physical Resistance/Sticking 1 1
Migration or Expulsion of Device 1 1
Unclear Information 1 1
Patient Device Interaction Problem 1 1
Detachment Of Device Component 1 1
Loss of or Failure to Bond 1 1
Noise, Audible 1 1
Component Falling 1 1
Activation, Positioning or Separation Problem 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
Fall 31 31
Implant Pain 26 26
Insufficient Information 20 20
Unspecified Infection 14 14
Failure of Implant 13 13
Fluid Discharge 13 13
No Code Available 12 12
Pain 11 11
Osteomyelitis 9 9
No Known Impact Or Consequence To Patient 7 7
Bacterial Infection 4 4
Inadequate Osseointegration 3 3
No Consequences Or Impact To Patient 3 3
Bruise/Contusion 3 3
Purulent Discharge 2 2
Missing Value Reason 2 2
Death 1 1
Subclinical Infection 1 1
Hip Fracture 1 1
Necrosis 1 1
Bone Fracture(s) 1 1
Localized Skin Lesion 1 1
Injury 1 1
Thrombosis/Thrombus 1 1
Osteolysis 1 1
Abscess 1 1
Limb Fracture 1 1
Headache 1 1
External Prosthetic Device Pain 1 1

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