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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, hemi-, acetabular, cemented, metal
Definition Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
Product CodeKWB
Regulation Number 888.3370
Device Class 3

MDR Year MDR Reports MDR Events
2014 28 28
2015 30 30
2016 3 3
2017 2 2
2018 6 6
2019 5 5
2020 9 9
2021 4 4
2022 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 16 16
Fracture 13 13
Adverse Event Without Identified Device or Use Problem 10 10
Device Dislodged or Dislocated 6 6
Appropriate Term/Code Not Available 6 6
Naturally Worn 6 6
Osseointegration Problem 5 5
Device Slipped 4 4
Break 4 4
Mechanical Problem 4 4
Migration or Expulsion of Device 4 4
Material Integrity Problem 3 3
Fitting Problem 2 2
Material Erosion 2 2
Patient Device Interaction Problem 2 2
Metal Shedding Debris 2 2
Corroded 2 2
Loose or Intermittent Connection 2 2
Detachment Of Device Component 2 2
Hole In Material 2 2
Loss of Osseointegration 2 2
Unstable 1 1
Expulsion 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Unintended Movement 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Degraded 1 1
Difficult to Insert 1 1
Unraveled Material 1 1
Device Packaging Compromised 1 1
Packaging Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Operates Differently Than Expected 1 1
Loss of or Failure to Bond 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 20 20
Pain 20 20
No Information 12 12
No Known Impact Or Consequence To Patient 11 11
Failure of Implant 8 8
Osteolysis 7 7
Unspecified Infection 6 6
Bone Fracture(s) 4 4
Joint Dislocation 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Injury 3 3
Reaction 3 3
Toxicity 3 3
Ambulation Difficulties 3 3
Necrosis 2 2
No Consequences Or Impact To Patient 2 2
Debris, Bone Shedding 1 1
Arthralgia 1 1
Sepsis 1 1
Disability 1 1
Inflammation 1 1
Hematoma 1 1
Spinal Column Injury 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Abscess 1 1
Collapse 1 1
Joint Laxity 1 1

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