It was reported that patient underwent a total hip arthroplasty in 1999, and a revision procedure (b)(6) 2006, due to dislocation.Subsequently, patient was revised on (b)(6) 2014, due to dislocation and wear.The freedom head and liner 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, number 8 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.¿ number 12 states, ¿wear and/or deformation of articulating surfaces." this report is number 2 of 3 mdrs filed for the same patient (reference 1825034-2014-02963 / 02965).
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