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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
Regulation Description Hip joint (hemi-hip) acetabular metal cemented prosthesis.
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
2019 5 5
2020 9 9
2021 4 4
2022 5 5
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Osseointegration Problem 4 4
Migration or Expulsion of Device 3 3
Mechanical Problem 2 2
Patient Device Interaction Problem 2 2
Fracture 2 2
Naturally Worn 2 2
Fitting Problem 1 1
Expulsion 1 1
Material Erosion 1 1
Material Integrity Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Difficult to Insert 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 7 7
Pain 7 7
No Code Available 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Unspecified Infection 2 2
No Known Impact Or Consequence To Patient 2 2
Debris, Bone Shedding 1 1
Arthralgia 1 1
Joint Dislocation 1 1
Spinal Column Injury 1 1
Osteolysis 1 1
Insufficient Information 1 1
Reaction 1 1
Collapse 1 1
Joint Laxity 1 1
Ambulation Difficulties 1 1

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