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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)
2019 2020 2021 2022 2023 2024
0 1 2 0 2 1

MDR Year MDR Reports MDR Events
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 60 60
Adverse Event Without Identified Device or Use Problem 47 47
Mechanical Problem 22 22
Insufficient Information 21 21
Fracture 10 10
Microbial Contamination of Device 8 8
Device Dislodged or Dislocated 8 8
Off-Label Use 6 6
Osseointegration Problem 6 6
Loss of Osseointegration 5 5
Device Fell 4 4
Failure to Osseointegrate 3 3
Unintended Movement 2 2
Break 2 2
Appropriate Term/Code Not Available 2 2
No Apparent Adverse Event 1 1
Loss of or Failure to Bond 1 1
Activation, Positioning or Separation Problem 1 1
Unclear Information 1 1
Physical Resistance/Sticking 1 1
Material Integrity Problem 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 29 29
Implant Pain 26 26
Insufficient Information 20 20
Failure of Implant 13 13
Fluid Discharge 13 13
Unspecified Infection 12 12
Osteomyelitis 9 9
Pain 7 7
No Code Available 6 6
Inadequate Osseointegration 3 3
Bruise/Contusion 3 3
Purulent Discharge 2 2
No Known Impact Or Consequence To Patient 2 2
Missing Value Reason 2 2
Bacterial Infection 2 2
Death 1 1
Hip Fracture 1 1
Necrosis 1 1
Bone Fracture(s) 1 1
Localized Skin Lesion 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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