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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, compression
Product CodeHWN
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 21 21
2015 8 8
2016 16 16
2017 29 29
2018 21 21
2019 37 37
2020 51 51
2021 88 88
2022 64 64
2023 83 83
2024 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Break 224 224
Device-Device Incompatibility 75 75
Crack 45 45
Naturally Worn 43 43
Material Deformation 26 26
Material Twisted/Bent 21 21
Mechanical Jam 11 11
Scratched Material 11 11
Fracture 10 10
Structural Problem 10 10
Component Missing 10 10
Material Fragmentation 10 10
Detachment of Device or Device Component 9 9
Contamination /Decontamination Problem 9 9
Appropriate Term/Code Not Available 8 8
Entrapment of Device 8 8
Fitting Problem 4 4
Material Too Rigid or Stiff 4 4
Difficult to Open or Close 3 3
Device Slipped 3 3
Unintended Movement 3 3
Difficult to Insert 3 3
Connection Problem 2 2
Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Failure to Align 2 2
Material Integrity Problem 2 2
Insufficient Information 2 2
Mechanical Problem 2 2
Physical Resistance/Sticking 2 2
Material Split, Cut or Torn 2 2
Corroded 2 2
Device Dislodged or Dislocated 2 2
Therapeutic or Diagnostic Output Failure 1 1
Material Erosion 1 1
Failure To Adhere Or Bond 1 1
Torn Material 1 1
Off-Label Use 1 1
Flare or Flash 1 1
Use of Device Problem 1 1
Positioning Failure 1 1
Material Frayed 1 1
Sparking 1 1
Loose or Intermittent Connection 1 1
Difficult to Remove 1 1
Device Inoperable 1 1
No Apparent Adverse Event 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Operates Differently Than Expected 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 268 268
No Consequences Or Impact To Patient 83 83
No Known Impact Or Consequence To Patient 42 42
Insufficient Information 25 25
No Information 19 19
No Patient Involvement 19 19
Foreign Body In Patient 14 14
No Code Available 9 9
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Swelling 2 2
Osteolysis 2 2
Erosion 2 2
Unspecified Infection 1 1
Not Applicable 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Inc. II Dec-01-2010
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