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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
Appropriate Term/Code Not Available 6 6
Device Dislodged or Dislocated 6 6
Naturally Worn 6 6
Osseointegration Problem 5 5
Break 4 4
Mechanical Problem 4 4
Migration or Expulsion of Device 4 4
Device Slipped 4 4
Material Integrity Problem 3 3
Loose or Intermittent Connection 2 2
Loss of Osseointegration 2 2
Patient Device Interaction Problem 2 2
Metal Shedding Debris 2 2
Fitting Problem 2 2
Detachment Of Device Component 2 2
Corroded 2 2
Hole In Material 2 2
Material Erosion 2 2
Loss of or Failure to Bond 1 1
Difficult to Insert 1 1
Degraded 1 1
Component Falling 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unraveled Material 1 1
Unstable 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Material Separation 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Packaging Problem 1 1
Unintended Movement 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 20 20
No Code Available 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
Reaction 3 3
Toxicity 3 3
Injury 3 3
Joint Dislocation 3 3
Ambulation Difficulties 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Necrosis 2 2
No Consequences Or Impact To Patient 2 2
Collapse 1 1
Arthralgia 1 1
Disability 1 1
Hematoma 1 1
Abscess 1 1
Debris, Bone Shedding 1 1
Inflammation 1 1
Sepsis 1 1
Spinal Column Injury 1 1
Joint Laxity 1 1
Insufficient Information 1 1
Foreign Body In Patient 1 1

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