Events

MATHYS Articular Replacement Prosthesis System 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 manufacturer #121 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    R1602-51
  • 사례 연번
    2012DM-0009024
  • 날짜
    2016-02-11
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=157
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • 데이터 추가 비고

Device

MATHYS Articular Replacement Prosthesis System
  • 모델명 / 제조번호(시리얼번호)
    BIONIT2 bipolar heads, references 1413-61-3, 1414-61- 3, 1415-61-3, 1416-61-3, 1417-61-3, 1418-61-3 and 1419-61-3, || specific lots.
  • 제품 설명
    For the partial or total artificial replacement of the joints of the body such as: hip, knee, shoulder and for the treatment of complex cases, osteoarthritis, joint instability, allowing to restore mobility, correct deformities, joint reconstruction, specific clinical indications according to the articulation and model or reference. Prosthesis for articular replacementMATHYS of shoulder primary osteoarthritis, secondary osteoarthritis, rheumatoid arthritis, post-traumatic osteoarthritis, arthropathy with rotator cuff tear (hamada grade III or IV) in young patients, joint metabolic deficiency (eg, chondrocalcinosis, hemosiderosis, urate arthropathies) , sequelae of fractures (healing of humeral head fractures, healing sinussion / pseudoarthrosis, necrosis of the head, blocked dislocations), avascular necrosis of the head (if there are sufficient bones), poly-fragmentary fractures and comminution of the humerus head with danger of disorders in fragment vascularization, proximal humerus fractures not treatable by osteosynthesis, secondary dislocation of the fragments subsequent to osteosynthesis in the proximal humerus, rotator cuff arthropathy (RDA), revision of total prosthesis or failed semiprosthesis in patients with pathological rotator cuff, in Certain tumor modifications of the proximal humerus. MATHYS joint replacement prosthesis of the hip: joint degenerative disease, such as primary or secondary coxarthritis, advanced loss of substance and functional loss of the hip joint caused by degenerative or post-traumatic or rheumatoid arthrosis, avascular onecrosis fracture of the femoral head or fracture of the femoral neck, after a previous surgical intervention, after osteosynthesis, reconstruction of the joint, arthrodesis, hemiarthroplasty or total hip replacement, post-traumatic coxarthrosis, coxarthrosis in mild osteoporosis, pathological osteoporosis, pronounced osteoporosis, revisions with slight loss of bone, extensive osseous bone reviews, fracture revisions
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA