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股骨远端骨水泥型模块化假体失败导致医疗器械相关不良事件:1例罕见病例报告

Distal Femur Cemented Modular Prosthesis Failure Causing a Medical Device-Related Adverse Event: A Report of a Rare Case.

作者信息

Agarwal Arohi, Singh Krishna, Jain Samyak, Singh Gagan, Dhamija Puneet, Mittal Piyush

机构信息

Materiovigilance, All India Institute of Medical Sciences Rishikesh, Rishikesh, IND.

Pharmacy Practice, Teerthanker Mahaveer College of Pharmacy, Moradabad, IND.

出版信息

Cureus. 2024 Jul 18;16(7):e64823. doi: 10.7759/cureus.64823. eCollection 2024 Jul.

Abstract

A distal femoral cemented modular prosthesis is a viable option for post-bone tumor and limb salvage procedures. The major reasons for implant failures are the poor quality of implants, mechanical stress, biochemical reactions, and extended period of the implant in vivo use. Rare incidences have been reported of distal femur prosthesis implant malfunctioning in a subject having osteosarcoma. Common adverse events associated with implant failure include surgical site infections, swelling, pain, revision of the surgical procedure, cyst formation, and build-up of metal debris on soft tissues. Our case report summarizes gross malfunctioning of a distal femur cemented modular prosthesis experienced by a 24-year-old post-operated osteosarcoma patient who developed excruciating sudden pain and the inability to bear weight on the right leg, with the sudden onset of these symptoms developing while turning in bed.

摘要

股骨远端骨水泥型模块化假体是骨肿瘤切除及肢体挽救手术后的一种可行选择。植入物失败的主要原因包括植入物质量差、机械应力、生化反应以及植入物在体内使用时间过长。有罕见病例报告称骨肉瘤患者的股骨远端假体植入出现故障。与植入物失败相关的常见不良事件包括手术部位感染、肿胀、疼痛、手术翻修、囊肿形成以及软组织上金属碎屑堆积。我们的病例报告总结了一名24岁骨肉瘤术后患者所经历的股骨远端骨水泥型模块化假体严重故障情况,该患者突然出现剧痛且无法用右腿承重,这些症状在其在床上翻身时突然发作。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/807d/11332967/2d0c7b983464/cureus-0016-00000064823-i01.jpg

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