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Безопасность имплантов
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« Сигнал — не частота. Знаменатель неизвестен »
Критические
12
официальный отзыв
Высокие
2
три и более типов источников
Под наблюдением
0
Информационные
12
Совпадений со складом
7
1 точных
Ключевые события
Waldemar Link GmbH & Co. KG (Mfg Site) есть у нас
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an al
DE · источники: openfda_enforcement, openfda_recall
United Orthopedic Corp. есть у нас
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
TW · источники: openfda_enforcement, openfda_recall
Medline Industries, LP
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of su
US · источники: openfda_enforcement
Think Surgical, Inc.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
US · источники: openfda_enforcement
Medline Industries, LP
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
US · источники: openfda_enforcement
Zimmer, Inc. есть у нас
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
US · источники: openfda_enforcement, openfda_recall
Medline Industries, LP
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
US · источники: openfda_enforcement
Howmedica Osteonics Corp.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is conta
US · источники: openfda_recall
Касается нас
На складе клиники 1 точных совпадений и 6 неточных.
Точное совпадение означает, что сошлись каталожный номер, UDI или партия. Это повод свериться с извещением регулятора, а не указание в отношении пациента.
География сигналов
Все события
| Дата | Производитель | Изделие | Неисправность | Страны | Источники | Уровень | У нас |
|---|---|---|---|---|---|---|---|
| 2026-08-11 | Waldemar Link GmbH & C | — | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. T | DE | openfda_enforcement, openfda_recall | критическое | да |
| 2026-08-05 | United Orthopedic Corp. | — | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem tr | TW | openfda_enforcement, openfda_recall | критическое | да |
| 2026-07-22 | Medline Industries, LP | — | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk | US | openfda_enforcement | критическое | — |
| 2026-07-15 | Think Surgical, Inc. | — | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the | US | openfda_enforcement | критическое | — |
| 2026-07-08 | Medline Industries, LP | — | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injec | US | openfda_enforcement | критическое | — |
| 2026-06-24 | Zimmer, Inc. | — | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment packa | US | openfda_enforcement, openfda_recall | критическое | да |
| 2026-06-24 | Medline Industries, LP | — | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation | US | openfda_enforcement | критическое | — |
| 2026-06-17 | Howmedica Osteonics Corp. | — | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Tria | US | openfda_recall | критическое | — |
| 2026-06-10 | Kico Knee Innovation Compa | — | The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet f | AU | openfda_enforcement | критическое | — |
| 2026-04-29 | DEPUY (IRELAND) | — | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | IE | openfda_enforcement, openfda_recall | критическое | — |
| 2026-03-10 | Waldemar Link GmbH & C | — | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudi | DE | openfda_recall | критическое | да |
| 2026-02-24 | Encore Medical, LP | — | Due to packaging discrepancy with incorrect product size mixed up. | US | openfda_recall | критическое | — |
| — | — | CPT Hip System | Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, carries a higher risk | CA, GB | health_canada, mhra_govuk | формируется | — |
| — | — | NexGen | The National Joint Registry (NJR) has identified that the NexGen Stemmed Option Tibial Components, when paired with eith | CA, GB | health_canada, mhra_govuk | формируется | — |
| — | — | — | An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) mod | GB | mhra_govuk | информация | — |
| — | Howmedica Osteonics Corpor | — | Devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five (5) | CA | health_canada | информация | — |
| — | Biomet Orthopedics | — | Potential sterile barrier packaging damaged caused by the exposed saw blade | CA | health_canada | информация | — |
| — | Spinal Kinetics LLC | M6-C | The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is i | GB | mhra_govuk | информация | — |
| — | — | Profemur | An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fract | GB | mhra_govuk | информация | — |
| — | Mako Surgical Corp. | — | An increase in the software error #3 (se3) error code when a Mako system shutdown or restart is not performed prior to s | CA | health_canada | информация | — |
| — | Biomet Orthopedics | Comprehensive | the stem implant did not fit in the inserter or that the inserter could not be detached from the stem | CA | health_canada | информация | — |
| — | Symbios | ORIGIN | The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision ra | GB | mhra_govuk | информация | — |
| — | NuVasive Specialized Ortho | MAGEC X System | The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satis | GB | mhra_govuk | информация | — |
| — | Howmedica Osteonics Corpor | Scorpio and Duracon | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. | CA | health_canada | информация | — |
| — | Zimmer Inc. | Zimmer M/L Taper | The outer package labeling and product etch are for a size 6, however, the implant is a size 4, and vice versa. | CA | health_canada | информация | да |
| — | NuVasive Specialized Ortho | PRECICE Titanium Systems | The MHRA is satisfied that the PRECICE Titanium subset of devices can now be used in adults in the UK. | GB | mhra_govuk | информация | — |
Профессиональный справочно-аналитический инструмент для специалистов здравоохранения. Не предназначен для диагностики, профилактики, мониторинга, предсказания, прогнозирования или лечения заболеваний у конкретного пациента. Не является медицинским изделием.
Уровень события назначается правилами слияния, а не моделью: официальный отзыв — критическое, три и более независимых типа источников — высокое. Сообщения MAUDE являются сигналом, а не частотой: знаменатель неизвестен.