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Model Number N/A |
Device Problems
Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)
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Patient Problems
Foreign Body Reaction (1868); Osteolysis (2377); Fluid Discharge (2686)
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Event Date 11/11/2013 |
Event Type
Injury
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Manufacturer Narrative
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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 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.This report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-05184 / 05185 / 05186).
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Event Description
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It was reported by the patient's legal counsel that patient underwent an initial left hip arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2013 due to adverse tissue reaction, femoral metal-induced bone resorption and osteolysis.During the procedure the head could not be removed due to cold-welding of the taper, resulting in removal of the femoral stem.Dark-brown fluid, grayish-brown debris and a vertical acetabular cup were noted.The head, taper, stem and cup were removed and replaced to complete the procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.
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Event Description
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It was reported by the patient's legal counsel that patient underwent an initial left hip arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2013 due to adverse tissue reaction, femoral metal-induced bone resorption, osteolysis, and elevated metal ion levels.During the procedure the head could not be removed due to cold-welding of the taper, resulting in removal of the femoral stem.Dark-brown fluid, grayish-brown debris, and gray fluid indicative of metallosis were noted.Operative report further noted a vertical acetabular cup, metal debris in femur osteolysis, hinge fracture in the trochanteric region, and large cavity defects.The head, taper, stem and cup were removed and replaced with competitor cup, cables, stem and biomet head and liner.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
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Search Alerts/Recalls
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