Legal counsel for patient reported that patient underwent total hip arthroplasty on (b)(6) 2008.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013, due to patient allegations of pain, discomfort, soreness, dysfunction, loss of mobility, damage to bone/tissue, metallosis, and elevated metal ion levels.A review of the invoice history confirmed the surgery dates and that the modular head, taper adapter and acetabular cup was removed and replaced during the revision surgery.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information (b)(6) 2013 was due to pain and elevated metal ion levels.The patient¿s operative report noted synovial fluid that was metal-tinged, soft tissue reaction, metallosis, metal reactive debris, lytic lesion, bone loss, and osteolysis.Additional information received in patient medical records noted that on (b)(6) 2013 patient¿s blood was tested.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ number 15 states, ¿elevated metal ion levels have been reported with metal-on-metal articulating surfaces.¿ this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2014-04271 / 04272 and -07139).
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