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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Ambulation Difficulties (2544)
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Event Date 09/13/2012 |
Event Type
Injury
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Event Description
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Legal counsel for patient reported that patient underwent right total hip arthroplasty in (b)(6) 2007.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, metal poisoning, metallosis and elevated metal ion levels.A review of invoice history indicates the initial hip surgery was performed on (b)(6) 2007.Invoice history confirmed the date of the revision surgery and that the acetabular cup and modular head were removed and replaced.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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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, ¿postoperative bone fracture and pain.¿ number 15 states, ¿elevated metal ion levels have been reported with metal-on-metal articulating surfaces.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-05699 / 05700).
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Manufacturer Narrative
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The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.
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Event Description
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Legal counsel for patient reported that patient underwent right total hip arthroplasty in (b)(6) 2007.Patient's legal counsel further reported that a revision procedure was performed on (b)(6), 2012 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, metal poisoning, metallosis and elevated metal ion levels.A review of invoice history indicates the initial hip surgery was performed on (b)(6), 2007.Invoice history confirmed the date of the revision surgery and that the acetabular cup and modular head were removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative report received noted patient underwent a right hip revision on (b)(6), 2012 due to pain and a soft mass.Revision operative report noted the presence of metal staining, fluid, synovitis, turbid yellow material, and patulous stretched capsular tissue.The acetabular cup, taper liner and modular head were removed and replaced.
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Search Alerts/Recalls
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