Following the surgical procedure, the patient complained of swelling, pain at the site, and experienced fever.Cultures did not show any infection, but the physician prescribed antibiotics.
|
The small, hemi great toe implant was not returned.It was kept by the patient after explantation.The implant surgery was 04/19/19, and the explant surgery was 05/17/19.The complaint concerns a patient's complaint of swelling at the site, and fever.At the time of explant, there were no signs of infection.Review of the dhr did not identify any non-conformance's associated with lot release.A two-year review did not identify any capas related to this instrument.A two-year review of the ncr database only found one, which was unrelated.This is the only complaint for this issue in two years.This implant is a part of the hemi 1st mpj "great toe" implant system (hemi).The hemi risk document includes an assessment of this failure mode.The predicted severity rating is a 3.Per the risk manament procedure, this corresponds with a "serious" severity level (results in injury or impairment requiring professional medical intervention).The final predicted risk level is "low".The hemi instructions for use (ifu) states, "the osteomed 1st mpj hemi implant system is comprised of implants made from cobalt chromium (astm f-799)." the ifu also states use of implants in this system is contraindicated "in patients previously sensitized to the implant material".This issue will be monitored through routine trending.
|