A report was received from dr.(b)(6) regarding the 2 defective lupine br ds suture anchor w/ orthocord that was used to his patient last (b)(6) 2015.The patient started to experience soreness 5 months after the procedure.On the 6th month, patient sought another shoulder surgeon (dr.(b)(6)) for second opinion.Several imaging studies and blood work-ups was done.Mri and xray revealed lysis of the greater tuberosity of the humerus.While ultrasound guided biopsy showed growth of pseudomonas aeruginosa.Additional information was received via email from the affiliate on 3-7-2016.Still checking if the lot numbers can be traced.The anchors were removed, 3rd or 4th week of (b)(6).The anchors were already disposed as those were infectious as per surgeon.
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The complaint device is not available for a physical evaluation and no further information is available to determine a root cause for this failure.It cannot be concluded that mitek product was the cause of the infection in patient.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.A complaint history of this product family revealed no other infection complaints in the last 3 years.This seems to be an isolated incident and it is a possibility that other factors may have contributed to the event.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).
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