It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr head and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr head.Similar complaints have been identified for the bhr cup.However, as bhr systems of this size are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The first revision was on the left secondary to dislocations performed in (b)(6) 2009.The root cause of the multiple dislocations cannot be concluded.It is unknown what impact the reported infection, the scar tissue and the it band, (on the left; atrophied), had on the dislocations.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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Bilateral patient.Plaintiff underwent medically-indicated revision of the bhr left hip implants on (b)(6) 2009 due to recurrent hip dislocation and joint pain.During this procedure, the bhr cup was not revised as it was found well fixed, and the bhr resurfacing head was explanted and exchanged with a full thr system consisting of a size 11 femoral stem, a +0mm modular sleeve and a bhr hemi head size 40mm.The patient was taken to the recovery room in stable condition.
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