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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)
2021 2022 2023 2024 2025 2026
2 0 2 1 3 3

MDR Year MDR Reports MDR Events
2021 25 25
2022 26 26
2023 60 60
2024 57 57
2025 49 49
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 87 87
Adverse Event Without Identified Device or Use Problem 66 66
Mechanical Problem 22 22
Insufficient Information 21 21
Fracture 17 17
Off-Label Use 8 8
Device Dislodged or Dislocated 8 8
Microbial Contamination of Device 7 7
Osseointegration Problem 5 5
Loss of Osseointegration 5 5
Failure to Osseointegrate 3 3
Break 2 2
Unintended Movement 2 2
Device Fell 2 2
No Apparent Adverse Event 2 2
Appropriate Term/Code Not Available 2 2
Unclear Information 1 1
Material Integrity Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 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 88 88
Fall 39 39
Implant Pain 34 34
Insufficient Information 22 22
Unspecified Infection 15 15
Failure of Implant 14 14
Fluid Discharge 14 14
Inadequate Osseointegration 11 11
Osteomyelitis 8 8
Bone Fracture(s) 5 5
Pain 5 5
Purulent Discharge 2 2
Abscess 2 2
Bruise/Contusion 2 2
Hip Fracture 1 1
Necrosis 1 1
Unspecified Musculoskeletal problem 1 1
Localized Skin Lesion 1 1
Thrombosis/Thrombus 1 1
Limb Fracture 1 1
Bacterial Infection 1 1
Headache 1 1
External Prosthetic Device Pain 1 1

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