| Developers: | Stryker Corporation |
| Date of the premiere of the system: | November, 2019 |
| Branches: | Pharmaceutics, medicine, health care |
2019: A withdrawal of the rejected batch
In the middle of November, 2019 Stryker issued the emergency notification on security concerning a prosthesis of an ankle joint of Star. The company warns that the risk of violation of structure of a prosthesis at its use was higher, than it was expected. Devices respond.
At complete prosthetics of an ankle joint on the adjoining surfaces of bones plastic or metal inserts are placed. The polyethylene prosthesis of an ankle joint of Star is shown as option of replacement of the articulate surfaces damaged at osteoarthrosis, post-traumatic arthritis or rheumatoid arthritis.
The Stryker company reports that violation of structure of a prosthesis can lead to development of the expressed pain syndrome, the inflammatory answer, damage of soft fabrics and formation of bubbles and also to other undesirable phenomena. Primary notification on security of October 11 concerned prostheses of an ankle joint of STAR which were issued till August 1, 2014 - approximately at this time Stryker purchased Small Bone Innovations and STAR companies (Scandinavian Total Ankle Replacement).
Representatives of Stryker said that they revealed decrease in durability of a prosthesis within the eight-year research which was conducted for assessment of post-registration security. When checking the level of destruction of polyethylene in a prosthesis was 13.79%. Besides, in the database about the undesirable phenomena of FDA MDR more than 100 cases connected with complete violation of polyethylene structure of a prosthesis and a change were registered.
According to Stryker, similar problems met much more often at patients with Star prostheses, than at other patients with complete replacement of an ankle joint.
Stryker included in mailing a special form of the answer with which help hospitals and doctors-surgeons should notify the company on acquaintance with the letter.[1]
Notes
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