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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tap, bone
Product CodeHWX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 43 43
2018 52 52
2019 125 125
2020 85 85
2021 91 91
2022 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Break 246 246
Device-Device Incompatibility 119 119
Contamination /Decontamination Problem 27 27
Fracture 19 19
Material Fragmentation 11 11
Entrapment of Device 10 10
Failure to Cut 6 6
Crack 6 6
Device Contamination with Chemical or Other Material 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Appropriate Term/Code Not Available 3 3
Device Handling Problem 3 3
Material Integrity Problem 3 3
Material Twisted/Bent 3 3
Difficult to Insert 3 3
Dull, Blunt 3 3
Difficult to Remove 3 3
Material Separation 2 2
Use of Device Problem 2 2
Detachment Of Device Component 2 2
Mechanical Jam 2 2
Naturally Worn 2 2
Detachment of Device or Device Component 2 2
Compatibility Problem 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Device Difficult to Maintain 1 1
Corroded 1 1
Failure To Adhere Or Bond 1 1
Material Puncture/Hole 1 1
Fitting Problem 1 1
Component Missing 1 1
Device Slipped 1 1
Device Or Device Fragments Location Unknown 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 157 157
No Consequences Or Impact To Patient 128 128
No Patient Involvement 88 88
No Known Impact Or Consequence To Patient 43 43
Foreign Body In Patient 24 24
No Code Available 12 12
Device Embedded In Tissue or Plaque 11 11
Injury 5 5
Insufficient Information 3 3
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bone Fracture(s) 2 2
Failure of Implant 2 2
Unspecified Infection 1 1
Nerve Damage 1 1
Non-union Bone Fracture 1 1
Post Operative Wound Infection 1 1
Not Applicable 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer GmbH II May-23-2019
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