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Model Number N/A |
Device Problems
Device Slipped (1584); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)
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Patient Problems
Necrosis (1971); Pain (1994); Weakness (2145); Toxicity (2333); Osteolysis (2377); Reaction (2414); Fluid Discharge (2686)
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Event Date 09/24/2014 |
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 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ 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." this report is number 2 of 2 mdr's filed for the same event (reference 1825034-2015-00148-1 / 05109).
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Event Description
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It was reported that the patient underwent a right total hip arthroplasty on (b)(6) 2009.Subsequently, a revision procedure was performed on (b)(6) 2014, due to patient allegations of pain and weakness.The patient reports that bone deterioration was allegedly noted during the revision procedure.The head was removed and replaced with a liner and head.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received reported that the revision procedure on (b)(6) 2014 occurred due to allegations of pain and aseptic loosening.During the procedure, fluid with necrotic tissue, necrosis of the sapsule and synovium, well-fixed stem, loose cup which had migrated to abducted position, mild metallosis and necrotic acetabular bone were noted.The head and cup were removed and replaced, and a liner was implanted to complete the procedure.
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Search Alerts/Recalls
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