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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device component, external, limb, ankle/foot
Product CodeISH
Regulation Number 890.3420
Device Class 1

MDR Year MDR Reports MDR Events
2018 7 7
2019 4 4
2020 5 5
2021 3 3
2022 2 2
2023 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Naturally Worn 15 15
Fracture 8 8
Break 4 4
Insufficient Information 4 4
Product Quality Problem 3 3
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 1 1
Mechanics Altered 1 1
Crack 1 1
Unintended Ejection 1 1
Mechanical Problem 1 1
Unintended System Motion 1 1
Fitting Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Fall 8 8
No Consequences Or Impact To Patient 7 7
Pain 3 3
Bone Fracture(s) 2 2
Injury 2 2
Limb Fracture 2 2
Unspecified Tissue Injury 2 2
Insufficient Information 1 1
Vertebral Fracture 1 1
Blister 1 1
Discomfort 1 1
Fatigue 1 1
Hip Fracture 1 1
Arthralgia 1 1
Depression 1 1
Joint Dislocation 1 1
Impaired Healing 1 1
Reaction 1 1
Irritability 1 1
Tooth Fracture 1 1
Ambulation Difficulties 1 1
Osteopenia/ Osteoporosis 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Skin Irritation 1 1
Tissue Damage 1 1
Optical Tissue, Breakdown Of 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Americas II Jul-05-2022
2 Ossur H / F II Jun-13-2023
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