prosthesis for joint replacement 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Hoffmann S.R.L || Smith & Nephew Orthopaedics Ag || Aap Biomaterials Gmbh || Smith & Nephew, Inc || Straits Orthopaedics (Mfg) Sdn. Bhd || Medicalplastic 에 의해 제조된 제품과 관련되어 있습니다.

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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
    R1604-166
  • 사례 연번
    2014DM-0001903-R1
  • 날짜
    2016-04-25
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 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

  • 모델명 / 제조번호(시리얼번호)
    Concerning the product R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM reference || 71339548, lot 15LM07776.
  • 제품 설명
    They are designed for partial or total artificial replacement of the joints of the body such as: hip, knee, shoulder and elbow. Indicated for the treatment of complex cases of joints, osteoarthritis, instability of the articulation. Allowing to restore mobility, correct deformities in joints, reconstruction of joints, with specific clinical indications according to the articulation and reference. Among other indications for use, SMITH & NEPHEW replacement hip prostheses are used for the treatment of: • for people who are undergoing primary revision surgery where other treatments or devices have failed in the rehabilitation of the hip joints as a result of trauma or non-inflammatory joint degenerative disease (NIOJO) • any of its diagnoses composed of laosteoarthritis. • Avascular necrosis. • Traumatic arthritis. • Capital slippage of the epiphysis. • melted hip • fracture of the pelvis, and the diastrophic variant. • degenerative inflammatory disease of the joints including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia • old, remote osteomyelitis with a long syncretization period, in which case, the patient should be warned of a risk of infection above normal after the operation. • Treatments of fractures of: non-union, the neck and the trochanter, of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy or resection of GIRDLESTONE, • fracture with dislocation of the hip.
  • Manufacturer