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单一设计的超高交联聚乙烯髋臼衬垫的骨折:美国食品和药物管理局自愿报告分析。

Fractures of a single design of highly cross-linked polyethylene acetabular liners: an analysis of voluntary reports to the United States Food and Drug Administration.

机构信息

Department of Orthopaedic Surgery, Division of Adult Reconstruction and Joint Replacement Surgery, Hospital for Special Surgery, New York, New York.

出版信息

J Arthroplasty. 2014 Jun;29(6):1231-5. doi: 10.1016/j.arth.2013.12.022. Epub 2013 Dec 19.

DOI:10.1016/j.arth.2013.12.022
PMID:24444569
Abstract

Polyethylene liner fracture is a risk associated with the use of highly cross-linked UHMWPE. We performed a review of the voluntary reports of fractured liners to the US Food and Drug Administration to determine if any risk factors could be identified. There have been 74 reports of fractured Trilogy, Longevity liners to the US Food and Drug Administration since 1999. Most cases utilized small acetabular shells (≤54 mm) combined with large diameter heads (≥36 mm). Liners less than 7 mm thick at the weight bearing or 4.8 mm thick at the rim should be used with caution. At revision surgery, malpositioned shells should be revised and the use of a thin liner should be avoided.

摘要

超高分子量聚乙烯衬垫的骨折是与高交联聚乙烯相关的使用风险。我们对美国食品和药物管理局收到的超高分子量聚乙烯衬垫骨折的自愿报告进行了审查,以确定是否可以识别任何风险因素。自 1999 年以来,美国食品和药物管理局收到了 74 份关于 Trilogy 和 Longevity 超高分子量聚乙烯衬垫骨折的报告。大多数病例使用了小髋臼壳(≤54mm)和大直径头(≥36mm)。在承重部位厚度小于 7mm 或边缘厚度小于 4.8mm 的衬垫应谨慎使用。在翻修手术中,应修改错位的髋臼壳,并避免使用薄衬垫。

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