Pinnacle litigation records received.Litigation alleges elevated cobalt and chromium levels, severe pain, popping and squeezing sound every time patient took a step, necrosis and symptoms consistent with alval and metalosis.It was also alleged that plaintiff suffered from implant loosening, swelling, inflammation, infection, damage to surrounding bone and tissue, problems walking, physical injury, bodily impairment, debilitating lack of mobility and the need to undergo revision surgery to explant the faulty implant.Doi: (b)(6) 2014 ; dor: (b)(6) 2017 (left hip).Patient is bilateral, see (b)(6) for right side.
|
No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|