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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
2017 6 6
2018 7 7
2019 4 4
2020 5 5
2021 3 3
2022 2 2
2023 21 21
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Naturally Worn 18 18
Fracture 13 13
Break 5 5
Insufficient Information 5 5
Product Quality Problem 3 3
Mechanical Problem 2 2
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 2 2
Device-Device Incompatibility 1 1
Fitting Problem 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Unintended Movement 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembled During Installation 1 1
Use of Device Problem 1 1
Unintended Ejection 1 1
Mechanics Altered 1 1
No Apparent Adverse Event 1 1
Migration 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Operates Differently Than Expected 1 1
Unintended System Motion 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 13 13
No Consequences Or Impact To Patient 10 10
Fall 9 9
Pain 5 5
Limb Fracture 4 4
Hip Fracture 3 3
Bone Fracture(s) 3 3
Impaired Healing 2 2
Joint Dislocation 2 2
Injury 2 2
Laceration(s) 2 2
Unspecified Tissue Injury 2 2
Tissue Damage 2 2
Optical Tissue, Breakdown Of 1 1
Arthralgia 1 1
Skin Irritation 1 1
Fatigue 1 1
Failure of Implant 1 1
No Information 1 1
Osteopenia/ Osteoporosis 1 1
Tooth Fracture 1 1
Blister 1 1
No Known Impact Or Consequence To Patient 1 1
Swelling 1 1
Concussion 1 1
Depression 1 1
Discomfort 1 1
Insufficient Information 1 1
Reaction 1 1
Subluxation 1 1
Hemorrhage/Bleeding 1 1
Irritability 1 1
Vertebral Fracture 1 1
Ambulation Difficulties 1 1
Bruise/Contusion 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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