An initial claim notice was received from the patient's attorney in (b)(6) 2018.No part numbers or incident information was provided at that time to confirm an arthrex product was involved.On (b)(6) 2019, the patient's legal representative provided medical records which reported the patient underwent a haglund's osteotomy, gastroc recession (left) on (b)(6) 2016.During the 2016 procedure, an arthrex ar-8928bc-cp, lot 10061945 (implant system, bio-composite achilles speedbridge) device was implanted.The patient reported significant improvement in pain until injuring his foot.The medical records note the patient was doing well post-surgery; however, the patient had an open ¿dehiscence¿ of the distal wound for over a year that went unresolved.The patient still used lidocaine patches but had stopped taking gabapentin.On (b)(6) 2018, the patient was admitted to the er for pain after developing a new opening along the distal incision.The patient went to the er when the wound on his heal re-opened.Er records note that the patient reported pain in his ankle and heel, increased fever, nausea, and increased redness to the heal.A ct of his ankle noted osteomyelitis of the calcaneus.The patient was admitted for further evaluation and treatment.Wound care was ordered; the podiatrist performed an incision and drainage, debridement of the calcaneus, and removed the hardware from his left foot on (b)(6) 2018.Bone pathologies and culture swabs were performed and the cultures were positive for staph.
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