Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 2007 and a right total hip arthroplasty on (b)(6) 2008.Legal counsel reports patient allegations of pain, inflammation, dysfunction, loss of range of motion, elevated cocr ion levels, metallosis and metal poisoning.Subsequently, patient¿s legal counsel reported patient underwent a right hip revision procedure on (b)(6) 2008.Review of invoice history confirmed the acetabular cup, modular head and taper adapter were removed and replaced.Patient¿s legal counsel further reported patient underwent a bilateral hip revision procedure on (b)(6) 2009.Additional information indicates patient underwent revision procedures on the right hip on (b)(6) 2010, (b)(6) 2011, and (b)(6) 2013 due to dislocation.A review of invoice history indicates patient underwent a revision procedure on (b)(6) 2011 on an unknown side.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.Operative reports were received for left hip revisions performed on (b)(6) 2011 and (b)(6) 2013.Information received in the revision operative notes indicates that the left hip revision performed on (b)(6) 2011 was due to pain and noted the presence of metallosis, joint effusion, staining of the capsular layer and a loose acetabular cup.The modular head and acetabular cup were removed and replaced.Operative notes received for the (b)(6) 2013 left hip revision noted the revision was due to instability and noted the presence of metallosis, a thickened crural fascial plane, straw-colored fluid, a loose acetabular cup, 2 broken screws, bone loss, and a scar ball.The acetabular cup and liner were removed and replaced with competitor¿s components.The modular head were removed and replaced.Operative reports were received for right hip revisions performed on (b)(6) 2008, (b)(6) 2009, (b)(6) 2010 and (b)(6) 2011.Operative report for the right hip revision performed on (b)(6) 2008 noted the revision was due to dislocations and noted the presence of a bloody effusion/hemarthrosis, disruption of the abductor mechanism and lack of bony ingrowth of the acetabular cup.The modular head, acetabular cup and liner were removed and replaced.Operative notes reported the right hip revision performed on (b)(6) 2009 was due to instability and noted the presence of fluid.The modular head, liner and locking ring were removed and replaced.Operative notes reported the right hip revision performed on (b)(6) 2010 was due to dislocation and noted the presence of chronic appearing seroma, fluid, a hemarthrosis/hematoma, scarring, the abductor mechanism pulled off, freedom liner was displaced and a fractured locking ring.The modular head, liner and locking ring were removed and replaced.Operative notes reported the right hip revision performed on (b)(6) 2011 was due to dislocation and noted the presence of bursitis, bloody serous fluid, inflammatory synovitis, dissociation of the modular head and liner and a fractured locking ring.The modular head, liner and locking ring were removed and replaced.
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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: "fatigue fracture of component may occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." and "material sensitivity reactions.¿ this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 18 of 21 mdrs filed for the same patient (reference 1825034-2014-00206 thru -00217 & -01716/-01722/ -01724 thru -01729).
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