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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, pelvifemoral resurfacing, metal/polymer, uncemented
Regulation Description Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
Definition Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head.
Product CodeOCG
Regulation Number 888.3410
Device Class 3

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 1 1
Failure of Implant 1 1

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