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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
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 5 5
Osseointegration Problem 4 4
Patient Device Interaction Problem 2 2
Mechanical Problem 2 2
Material Integrity Problem 1 1
Expulsion 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 6 6
Pain 3 3
Unspecified Infection 2 2
Arthralgia 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Joint Laxity 1 1
Ambulation Difficulties 1 1

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