Pinnacle Acetabular Shell with Porocoat - Acetabular shell

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
07-08-2019

可用日期:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

类:

Class III

厂商:

DePuy Ireland UC Loughbeg Ringaskiddy, Co Cork Ireland

治疗领域:

43167 - Acetabular shell

疗效迹象:

The Pinnacle Acetabular Shells with Porocoat are titanium shells coated in Porocoat (titanium sintered beads) to enable biological fixation into the prepared acetabulum. Pinnacle Acetabular Shells with Porocoat are indicated for cementless applications. Additionally, the Pinnacle Acetabular Shells with Porocoat are available with of a range of holes to enable screws. An appropriate liner is then placed into the implanted shell. The Pinnacle Acetabular Shell with Porocoat is an acetabular shell used during primary or revision total hip arthroplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

授权状态:

A

授权日期:

2019-07-30

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